|
Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name |
| 11/22/19 | Amneal | Ranitidine
Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution,
USP), 15 mg/mL | Due to
potential N-Nitrosodimethylamine (NDMA) amounts above levels established by
the FDA | Amneal
Pharmaceuticals, LLC |
| 11/19/19 | PrecisionDose | Ranitidine
Oral Solution, USP 150 mg/10 mL | Potential
presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA | Precision
Dose Inc. |
| 11/15/19 | GSMS Incorporated | Ranitidine
HCl 150mg and 300mg Capsules | Potential
presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA | GSMS,
Inc. |
| 11/13/19 | Silver Bullet | Male
Enhancement Capsules | Due to
unapproved active ingredient (sildenafil) | Nature’s
Rx |
| 11/8/19 | AHP | Ranitidine
Liquid Unit Dose Cups | NDMA
(Nitrosodimethylamine) impurity | American
Health Packaging |
| 11/8/19 | Up2 | Up2
THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement | Product
is tainted with sildenafil | Med Man
Distribution |
| 11/6/19 | Aurobindo & DG Health | Ranitidine | NDMA
(Nitrosodimethylamine) | Aurobindo
Pharma USA, Inc. |
| 11/5/19 | Viatrexx | Sterile
injectable products | Lack of
sterility assurance | Viatrexx
Bio Incorporated |
| 11/1/19 | Fagron | LETS GEL
KIT Convenience Packs | Potentially
contain microbial contamination in the non-sterile Suturagel | Fagron
Inc. |
| 10/30/19 | ICU Medical, Inc. | Lactated
Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP | Due to
the presence of particulate matter | ICU
Medical, Inc. |
| 10/26/19 | Mylan Pharmaceuticals Inc. | Alprazolam
Tablets, USP C-IV 0.5 mg | Potential
presence of foreign substance | Mylan
Pharmaceuticals Inc. |
| 10/25/19 | Lannett Company, Inc. | Ranitidine
Syrup (Ranitidine Oral Solution, USP), 15mg/mL | Due to
above levels of N-Nitrosodimethylamine (NDMA) | Lannett
Company, Inc. |
| 10/25/19 | Novitium Pharma | Ranitidine
Hydrochloride Capsules 150 mg and 300 mg | May
contain N-Nitrosodimethylamine (NDMA) | Novitium
Pharma |
| 10/23/19 | Dr. Reddy’s, Kroger, Walgreens, and others | Ranitidine
Tablets & Capsules | Contains
N-Nitrosodimethylamine (NDMA) | Dr.
Reddy’s Laboratories Ltd. |
| 10/23/19 | Sanofi | Zantac
150, Zantac 150 Cool Mint, Zantac 75 (OTC Products) | May
Contain N-Nitrosodimethylamine (NDMA) | Sanofi |
| 10/23/19 | Perrigo Company plc | Ranitidine
(all pack sizes) | Presence
of N-Nitrosodimethylamine (NDMA) | Perrigo
Company plc |
| 10/22/19 | Green Lumber | Dietary
supplements for male sexual enhancement | Contains
Tadalafil | GL
Holdings |
| 10/10/19 | Innoveix Pharmaceuticals, Inc. | Injectable
Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2 | Potential
lack of sterility assurance | Innoveix
Pharmaceuticals, Inc. |
| 9/25/19 | Apotex Corp. | Ranitidine
Tablets 75mg and 150mg | Contain
a nitrosamine impurity called N-nitrosodimethylamine (NDMA) | Apotex
Corp. |
| 9/23/19 | Sandoz Inc. | Ranitidine
Hydrochloride Capsules | Due to
an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) | Sandoz
Inc. |
| 9/19/19 | Torrent Pharma | Losartan
Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets,
USP | Due to
the Detection of N-Methylnitrosobutyric acid (NMBA) | Torrent
Pharmaceuticals Limited |
| 9/16/19 | Macho | MACHO
ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT | Undeclared
Tadalafil | Fitoterapia
USA Inc. |
| 9/12/19 | Darmerica LLC | Quinacrine
Dihydrochloride, bulk API powder | Label
mix-up | Darmerica
LLC |
| 9/12/19 | KRS Global Biotechnology | Human
Sterile Drug Products | Lack of
Sterility Assurance | KRS
Global Biotechnology |
| 9/9/19 | Major Pharmaceuticals | Milk of
Magnesia Oral Suspension 2400 mg/30 ml | Microbial
Contamination | Plastikon
Healthcare |
| 9/6/19 | Hospira Inc. | Bacteriostatic
Water for Injection | Potential
Lack of Sterility Assurance | Hospira
Inc. |
| 9/5/19 | Natpara | Parathyroid
Hormone for Injection | Potential
presence of rubber particulate | Takeda
Pharmaceutical Company Limited |
| 8/30/19 | AmEx Pharmacy | Bevacizumab
1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB
Injectable | Potential
for non-sterility | Pacifico
National, Inc. dba AmEx Pharmacy |
| 8/22/19 | Dechra Veterinary Products | Veterinary
ophthalmic drug products | Due to
concerns of QA controls in the manufacturing facility | Altaire
Pharmaceuticals, Inc. |
| 8/15/19 | RELPAX | RELPAX®
(eletriptan hydrobromide) 40 mg tablets | Microbiological
Contamination | Pfizer
Inc |
| 8/8/19 | TAT Balm, Naturally HL | 4%
Lidocaine topical cream & liquid gel products | Microbiological
Contamination and Superpotency | Ridge
Properties LLC DBA Pain Relief Naturally |
| 7/24/19 | Herbal Doctor Remedies | Drug
products | All
products have been marketed without FDA approval and were manufactured
outside of the controls required by current Good Manufacturing Practices
(cGMP) | Herbal
Doctor Remedies |
| 7/23/19 | Cadista | Drospirenone
and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg | Due to
out of specification (OOS) dissolution results at the 3-month stability time
point | Jubilant
Cadista Pharmaceuticals Inc. |
| 7/16/19 | OCuSOFT | Prescription
(RX) and Over-the-Counter (OTC) Ophthalmic products | Due to
lack of sterility assurance | Altaire
Pharmaceuticals, Inc., |
| 7/15/19 | Altaire Pharmaceuticals, Inc. | OTC and
Rx Ophthalmic Products | Due to
lack of sterility assurance | Altaire
Pharmaceuticals Inc. |
| 7/15/19 | Alvogen | Fentanyl
Transdermal System | Due to
Product Mislabeling | Alvogen |
| 7/15/19 | Legacy | Losartan
Potassium USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Legacy
Pharmaceutical Packaging |
| 7/15/19 | Equate and Support Harmony | Over-the-Counter
(OTC) drug products | Potential
for nonsterility | Altaire
Pharmaceuticals, Inc. |
| 7/10/19 | CVS Health | Multiple
Ophthalmic Products | Due to
lack of assurance of sterility | Altaire
Pharmaceuticals, Inc |
| 7/5/19 | Equate and Support Harmony | Over-the-Counter
(OTC) drug products | Potential
for nonsterility | Altaire
Pharmaceuticals, Inc. |
| 7/3/19 | Perrigo | Ophthalmic
ointments | Potential
for nonsterility | Altaire
Pharmaceuticals, Inc. |
| 7/2/19 | Fresenius Kabi, Novaplus | Fluorouracil
Injection | Potential
for glass particulate | Fresenius
Kabi USA, LLC |
| 6/28/19 | PharMEDium | 0.5
mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe | The
electronic customer ordering system stated it is sulfite-free, but the
product contains sulfite. | PharMEDium
Services, LLC |
| 6/26/19 | Macleods | Losartan
Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination
tablets | Presence
of NMBA impurity | Macleods
Pharmaceutical Limited |
| 6/20/19 | Infusion Options Inc. | All
sterile products within expiry | Lack of
Sterility Assurance | Infusion
Options Inc. |
| 6/18/19 | Premier Pharmacy Labs | All
Products Intended to be Sterile | Lack of
Sterility Assurance | Premier
Pharmacy Labs Inc |
| 6/18/19 | RXQ Compounding LLC | All
sterile human and animal products within expiry. | Lack of
Sterility Process Assurance | RXQ
Compounding LLC |
| 6/11/19 | GSMS Inc. | Losartan
potassium tablets | Detection
of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) | Teva
Pharmaceuticals USA, Inc. |
| 5/29/19 | Pecgen DMX, | PECGEN
DMX, 16 oz, liquid cough syrup | Incorrect
dosage on label | NOVIS PR
LLC |
| 5/28/19 | Heritage | Amikacin
Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate
Injection, USP, 10mg/2mL (5mg/mL) | Sterility
Failure | Heritage
Pharmaceuticals Inc. |
| 5/23/19 | Pharm D Solutions | Sterile
Compounded Drug Products | Lack of
sterility assurance | Pharm D
Solutions, LLC |
| 5/12/19 | Promacta | Promacta
12.5 mg oral suspension | Due to
Potential Peanut Contamination | Novartis |
| 5/3/19 | WP Westminster, more | Irbesartan
Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | ScieGen
Pharmaceuticals, Inc |
| 5/3/19 | Par Pharmaceutical | Mycophenolate
Mofetil for injection | Foreign
Material | Par
Pharmaceutical, Inc. |
| 5/3/19 | Heritage | Losartan
Potassium Tablets USP | Lack of
sterility | Vivimed |
| 5/2/19 | Endo Pharmaceuticals | Robaxin®
(methocarbamol tablets, USP) 750mg Tablets | Incorrect
Daily Dosing Information on Label | Endo
Pharmaceuticals |
| 4/30/19 | Sagent Pharmaceuticals | Ketorolac
Tromethamine Injection | Lack of
Sterility | Sagent
Pharmaceuticals |
| 4/29/19 | AmEx Pharmacy | Bevacizumab
1.25mg/0.05mL 31G Injectable | Product
Defect | AmEx
Pharmacy |
| 4/26/19 | GSMS Incorporated | Losartan
Potassium 25 mg and 100 mg Tablets USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Teva
Pharmaceuticals USA, Inc |
| 4/18/19 | Torrent Pharmaceuticals Limited | Losartan
potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets,
USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Torrent
Pharmaceuticals Limited |
| 4/12/19 | Platinum 40000 | Aphrodisiac
capsules | Unapproved
Ingredient | SD
Imports |
| 3/28/19 | Legacy | Losartan
Potassium USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Legacy
Pharmaceutical Packaging |
| 3/25/19 | Leopard | Dietary
Supplement | Undeclared
Sildenafil | USA LESS |
| 3/20/19 | DG™/health NATURALS | baby
Cough Syrup + Mucus | Potential
to be contaminated with Bacillus cereus/ Bacillus circulans | Kingston
Pharma, LLC |
| 3/19/19 | Legacy | Losartan
Potassium USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Legacy
Pharmaceutical Packaging |
| 3/18/19 | Mylan | Levoleucovorin
Injection, 250 mg/25 mL | Presence
of particulate matter | Mylan
Institutional LLC |
| 3/15/19 | Legacy | Losartan
Potassium USP | Due to
the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid
(NMBA) | Legacy
Pharmaceutical Packaging |
| 3/15/19 | Hospira | Sodium
bicarbonate injection USP | Presence
of Particulate Matter | Hospira,
Inc. |
| 3/13/19 | Stokes Healthcare | Pilocarpine
opthalmic solution | Due to a
High Level of Preservative | Stokes
Healthcare, Inc. |
| 3/7/19 | Aurobindo Pharma USA, Inc. | Valsartan
Tablets USP | Due to
detection of N-Nitrosodiethylamine (NDEA) | American
Health Packaging |
| 3/6/19 | Life-Line tm | Additive
for human drinking water | Contaminated
with Pseudomonas aeruginosa | McDaniel
Life-Line LLC |
| 3/1/19 | Torrent Pharma | Losartan
Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Torrent
Pharmaceuticals Limited |
| 3/1/19 | Aurobindo, Acetris | Valsartan
and Amlodipine and Valsartan tablets | Due to
the detection of NDEA (N-Nitrosodiethylamine) Impurity | AurobindoPharma
USA, Inc. |
| 3/1/19 | Apotex Corp. | Drospirenone
and Ethinyl Estradiol Tablets, USP | Possibility
of Missing/Incorrect Tablet Arrangement | Apotex
Corp. |
| 2/28/19 | Camber Pharmaceuticals, Inc. | Losartan
Tablets USP 25 mg, 50 mg, and 100 mg | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Camber
Pharmaceuticals, Inc. |
| 2/26/19 | ChemoLock and ChemoClave | Vial
Spikes | Due to
the Potential for Burr Particulate | ICU
Medical, Inc. |
| 2/25/19 | Golean Detox | Dietary
Supplement for Weight Loss | Mislabeling | Golean
Detox USA |
| 2/22/19 | Macleods | Losartan
Potassium/Hydrochlorothiazide Combination Tablets | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Macleods
Pharmaceuticals Limited |
| 2/8/19 | McDaniel Life-Line | Indian
Herb (topical) | Unapproved
drug. Marketed without an approved NDA/ANDA | McDaniel
Life-Line LLC |
| 2/4/19 | Dr. Reddy’s Laboratories Ltd. | Infusion
Bags (Levetiracetram in 0.54% Sodium Chloride Injection) | Mislabeling | Dr.
Reddy’s Laboratories Ltd. |
| 1/29/19 | CVS, Equate | Oral
ibuprofen | Higher
Concentration of Ibuprofen | Tris
Pharma, Inc. |
| 1/22/19 | Torrent Pharmaceuticals Limited | Losartan
potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets,
USP | Lack of
Sterility | Torrent
Pharmaceuticals Limited |
| 1/18/19 | Prinston Pharmaceutical Inc. dba Solco
Healthcare LLC | Irbesartan
and Irbesartan HCTZ Tablets | Due to
the detection of NDEA (N-Nitrosodiethylamine) Impurity | Prinston
Pharmaceutical Inc. dba Solco Healthcare LLC |
| 1/8/19 | Sun Pharma | Vecuronium
Bromide for Injection | Potential
Foreign Material | Sun
Pharmaceutical Industries, Inc |
| 1/8/19 | Rhino | Rhino 5K
capsules | Undeclared
Sildenafil and Tadalafil | Happy
Together, Inc. |
| 1/5/19 | Lupin Pharmaceuticals, Inc. | Ceftriaxone
for Injection, USP | Foreign
Material | Lupin
Pharmaceuticals, Inc. |
| 1/3/19 | Torrent Pharmaceuticals Limited | Losartan
potassium tablets, USP | Due to
the detection of trace amounts of N-nitrosodiethylamine (NDEA) | Torrent
Pharmaceuticals Limited |
| 1/2/19 | Lubrisine | Eye
Drops | Sterility
Concerns and Undeclared Colloidal Silver | Results
RNA LLC |
| 12/31/18 | Aurobindo | Amlodipine
Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Aurobindo
Pharma USA, Inc. |
| 12/20/18 | Torrent Pharmaceuticals Limited | Losartan
potassium tablets, USP | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Torrent
Pharmaceuticals Limited |
| 12/19/18 | Terrific Care LLC dba MedEx Supply | Roche
CoaguChek test strips | Inaccurately
reporting high INR test results | Terrific
Care, LLC. / Medex Supply Dist, Inc. |
| 12/17/18 | Envoachem Pharmaceuticals | Dyural-40
and Dyural-80 | Due to
Latex Hazard | Asclemed
USA Inc dba Envoachem Pharmeceuticals |
| 12/6/18 | Family Wellness, CVS, Equate | Infants’
Ibuprofen | Due to
Potential Higher Concentrations of Ibuprofen | Tris
Pharma |
| 12/4/18 | Mylan | Valsartan-containing
products | Due to
the detection of NDEA (N-Nitrosodiethylamine) Impurity | Mylan
Pharmaceuticals |
| 11/27/18 | Teva Pharmaceuticals | Amlodipine/Valsartan
Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination
Tablets | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Teva
Pharmaceuticals |
| 11/21/18 | Fresenius Kabi | Sodium
Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride
Injection, USP, 0.9%, 20 mL fill in a 20 mL vial | Due to
Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex | Fresenius
Kabi USA |
| 11/12/18 | Oscor | Temporary
Bipolar Pacing Lead, Model TB | Connector
cap housing may slide and potentially expose the connection wire | Oscor
Inc. |
| 11/9/18 | Losartan | Potassium
Hydrochlorothiazide | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Sandoz
Inc |
| 11/7/18 | Puriton | Puriton
Eye Relief Drops, 0.5 oz. (15ml) bottle | Due to
Non-Sterile Production Conditions | Kadesh
Inc. |
| 11/2/18 | ORTHO-NOVUM | ORTHO-NOVUM
1/35 and 7/7/7 | Due to
Incorrect Veridate Dispenser Instructions | Janssen
Pharmaceuticals, Inc.
|
| 10/29/18 | Aurobindo Pharma Limited | Irbesartan
Drug | Due to
detection of NDEA (N-Nitrosodiethylamine) Impurity | Aurobindo
Pharma Limited |
| 10/22/18 | Promise Pharmacy | Prednisolone
and Gatifloxacin Ophthalmic Solution | Due to
Small Particulate Floating in the Solution | Promise
Pharmacy |
| 10/18/18 | Zero Xtreme | Dietary
Supplement for Weight Loss | Due to
Presence of Undeclared Sibutramine | Fat
Burners Zone |
| 10/10/18 | ReGen Series | All
ReGen Series products | Adverse
reactions | Liveyon,
LLC |
| 10/10/18 | Sprayology | Homeopathic
Aqueous-Based Medicines | Possible
microbial contamination | Eight
and Company LLC, dba Sprayology |
| 9/13/18 | NeoRelief | Muscle | Due to
Possible Microbial Contamination | BioLyte
Laboratories |
| 9/10/18 | Pharm D Solutions | Compounded
drugs | Lack of
Sterility | Pharm D
Solutions LLC |
| 9/7/18 | SCA Pharmaceuticals | Furosemide
100 mg in 0.9% Sodium Chloride 100 mg bag | Due to
Presence of Precipitate | SCA
Pharmaceuticals LLC (“SCA Pharma”) |
| 9/7/18 | Camber Pharmaceuticals | Montelukast
Sodium Tablets, USP 10mg | Mislabeling | Camber
Pharmaceuticals, Inc |
| 9/6/18 | Beaumont Bio Med Homeopathic | Homeopathic
oral sprays | Due to
Possible Microbial Contamination | Beaumont
Bio Med, Inc. |
| 8/29/18 | CVS, Rhinall, Humist, more | Nasal
Products and Baby Oral Gels | Microbial
Contamination | Product
Quest Manufacturing LLC |
| 8/29/18 | Neuroveen, Respitrol, Thyroveev, Compulsin | Homeopathic
Medicines | Due to
Possible Microbial Contamination | HelloLife,
Inc. |
| 8/28/18 | Dr. King’s | Homeopathic
products for human and animal use | Microbial
Contamination | King Bio |
| 8/28/18 | Children’s Advil | Ibuprofen
Oral Suspension | Dosage
cup provided is marked in teaspoons and the instructions on the label are
described in milliliters (mL) | Pfizer,
Inc. |
| 8/27/18 | Accord | Hydrochlorothiazide
Tablets USP 12.5 mg | Due to
Labeling Mix-up | Accord
Healthcare Inc. |
| 8/24/18 | Torrent Pharmaceuticals Limited | Valsartan/Amlodipine/HCTZ;
Valsartan/Amlodipine; and Valsartan tablets | Impurity | Torrent
Pharmaceuticals Limited |
| 8/24/18 | KB, DK, more | Homeopathic
products | Microbial
contamination | King Bio |
| 8/17/18 | Torrent | Valsartan/Amlodipine/HCTZ
Tablets | Due to
The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) | Torrent
Pharmaceuticals |
| 8/16/18 | Blissful Remedies | Products
Containing Kratom | Due to
High Microbial Loads Contamination | World
Organix, LLC |
| 8/14/18 | Kratom Powder Capsule | Kratom
Powder Capsule | Potential
to be contaminated with Salmonella | Blissful
Remedies |
| 8/10/18 | Westminster Pharmaceuticals, LLC | Levothyroxine
and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120
mg | Due to
Risk of Adulteration | Westminster
Pharmaceuticals, LLC |
| 8/9/18 | Camber Pharmaceuticals, Inc. | Valsartan
Tablets, USP, 40mg, 80mg, 160mg and 320mg | Detection
of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity | Camber
Pharmaceuticals, Inc. |
| 8/8/18 | Actavis | Valsartan
and Valsartan Hydrochlorothiazide Tablets | Impurity | Teva
Pharmaceuticals USA |
| 8/8/18 | CVS Health | 12 Hour
Sinus Relief Nasal Mist | Due to
Microbiological Contamination | Product
Quest Manufacturing (“Product Quest”) |
| 7/31/18 | Auromedics | Piperacillin
and Tazobactam for injection, USP 3.375 g | Due to
Presence of Particulates Identified as Glass and Silicone Material | AuroMedics
Pharma |
| 7/28/18 | Ranier’s RX Laboratory | Compounded
drug products | Due to
Lack of Sterility Assurance | Ranier’s
RX Laboratory |
| 7/20/18 | Dr. King’s, Dr. King’s Aquaflora | Homeopathic
liquids: Candida liquid, lymph detox liquid, baby teething liquid | microbial
contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia
Multivorans. | King Bio
Inc. |
| 7/18/18 | Prinston Pharmaceutical Inc. dba Solco
Healthcare LLC | Valsartan
Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide
Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg | Due to
Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine
(NDMA) | Prinston
Pharmaceutical Inc. dba Solco Healthcare LLC |
| 7/16/18 | Major Pharmaceuticals | Valsartan
tablets, 80mg USP and 160 mg USP | may
contain the probable carcinogen Nnitrosodimethylamine (NDMA) | Major
Pharmaceuticals |
| 7/2/18 | Fagron Sterile Services | Neostigmine
Methylsulfate 5 mL Syringes | Mislabeling | Fagron
Sterile Services |
| 6/27/18 | Hospira | Daptomycin
for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial | Adverse
event reports indicative of infusion reactions | Hospira
Inc. |
| 6/21/18 | Gaia Ethnobotanical | Kratom
Products | Salmonella | Gaia
Ethnobotanical, LLC |
| 6/4/18 | Hospira | Naloxone
Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™
Single-use cartridge Syringe System | Potential
of Foreign Material | Hospira
Inc. |
| 5/31/18 | Apotex | Fluticasone
Propionate Nasal Spray | Small
Glass Particles | Apotex
Corp. |
| 5/31/18 | HeartMate 3 | Left
Ventricular Assist Device | potential
safety risk to patients, such as low blood flow or clotting. | Abbott |
| 5/29/18 | Taytulla | Birth
control capsules | Due to
Out of Sequence Capsules | Allergan |
| 5/25/18 | X-Jow, Acne Shave | Pain
Gel, Moisturizer, Shave Cream | Bacteria | Shadow
Holdings |
| 5/23/18 | Ethanol Extraction/Lake Michigan Distilling
Company, LLC | 95%
Ethyl Alcohol product | Methanol | Lake
Michigan Distilling Company, LLC dba Ethanol Extraction |
| 5/18/18 | MBI Distributing, Inc. | Various
Homeopathic Products | Lack of
Adequate Controls | MBI
Distributing, Inc. |
| 5/17/18 | 7K and Poseidon | 7K and
Poseidon 4500 Dietary Supplements | Undeclared
Sildenafil and Tadalafil | Shoreside
Enterprises |
| 5/14/18 | AuroMedics Pharma LLC | Piperacillin
and Tazobactam for injection, USP 3.375 g/vial | Due to
Presence of Glass Particulates | AuroMedics
Pharma LLC |
| 5/14/18 | AuroMedics Pharma LLC | Ampicillin
and Sulbactam for Injection USP, 3 grams/ Single-Dose vial | Visible
Particulate Matter | AuroMedics
Pharma LLC |
| 5/14/18 | Apotex Corporation | Piperacillin
and Tazobactam for Injection | Ingredient
Level | Apotex
Corporation |
| 4/13/18 | AMA Wholesale Inc. | Rhino 69
Extreme 50000 capsules | Undeclared
tadalafil | AMA
Wholesale Inc. |
| 4/11/18 | Premier Pharmacy Labs | Sterile
Injectable Drug Products | Due to a
Potential Lack of Sterility Assurance | Premier
Pharmacy Labs |
| 4/3/18 | PASTA DE LASSAR ANDROMACO | Pasta De
Lassar Andromaco Skin Protectant | Due to
Potential Contamination of high levels of yeast, mold, and bacteria | MarcasUSA,
LLC |
| 4/3/18 | PASTA DE LASSAR ANDROMACO | Pasta De
Lassar Andromaco Skin Protectant | Due to
Potential Contamination of high levels of yeast, mold, and bacteria | MarcasUSA,
LLC |
| 3/22/18 | BD | Vacutainer
tubes | Inaccurate
lead test results | BD |
| 3/16/18 | Bayer | Alka-Seltzer
Plus | Mislabeling-The
ingredients on the front sticker may not match the actual product in the
carton | Bayer |
| 3/6/18 | Sagent | Methylprednisolone
Sodium Succinate for Injection, USP 40mg, 125mg, and 1g | Due to
High Out of Specification Impurity Results | Sagent
Pharmaceuticals |
| 3/5/18 | Hospira, Inc. | Hydromorphone
HCL Injection, USP | Due to
The Potential for Empty or Cracked Glass Vials | Hospira,
Inc. |
| 2/23/18 | Hospira, Novaplus | Labetalol
Hydrochloride Injection, USP | Due to
Potential Of Cracked Glass At The Rim Surface Of The Vials | Hospira,
Inc. |
| 2/15/18 | AVpak | Acyclovir
Tablet, USP, 400mg, 50ct Unit Dose | Due to
Product Mix-up | Apace
Packaging LLC |
| 2/9/18 | Bella Pharma | All lots
of unexpired sterile drug products | Lack of
Sterility | Bella
Pharmaceuticals, Inc. |
| 2/9/18 | LaBri’s Body Health | Dietary
Supplement | Mislabeling | Envy Me |
| 2/8/18 | Doctor Manzanilla | Allergy,
cough medicine | Burkholderia
Cepacia | Mid
Valley Pharmaceutical |
| 2/8/18 | Man of Steel | Man of
Steel 1 and Man of Steel 2 | Due to
Presence of Undeclared Sildenafil | Man of
Steel |
| 2/8/18 | Edex | Alprostadil
for injection | Potential
Lack of Sterility Assurance | Endo
Pharmaceuticals Inc. |
| 2/8/18 | Astrazeneca | professional
(physician) sample BRILINTA (ticagrelor) 90mg tablets | Another
medicine present | Astrazeneca |
| 2/8/18 | Uproar, Cummor, Zrect, Monkey Business and
others | Dietary
Supplement | Undeclared
Active Ingredients tadalafil, sildenafil and analogues | Organic
Herbal Supply, Inc. |
| 2/8/18 | Hospira, Inc. | Vancomycin
Hydrochloride for injection | Due to
the Presence of Particulate Matter | Hospira,
Inc. |
| 2/8/18 | Genentech | Activase®
(alteplase) 100mg vials | Due to
Lack of Sterility Assurance | Genentech |
| 2/8/18 | Amneal Pharmaceuticals LLC | Lorazepam
Oral Concentrate, USP 2mg/mL | Due to
Misprinted Dosing Droppers | Amneal
Pharmaceuticals LLC |
| 2/8/18 | Baxter | intravenous
(IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic
Container and 70% Dextrose Injection (2000 mL) USP | Labeled
as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets | Baxter
International Inc. |
| 2/8/18 | Rugby | Diocto
Liquid and Diocto Syrup | Potential
contamination with Burkholderia cepacia | Rugby®
Laboratories |
| 2/8/18 | Hyland’s | Baby
teething tablets and Nightime teething tablets | Mislabeling | Standard
Homeopathic Company |
| 2/8/18 | Bristol-Myers Squibb | Eliquis
(apixaban) 5 mg Tablets | Potential
Labeling Issue | Bristol-Myers
Squibb |
| 2/8/18 | Piyanping | Anti-Itch
Lotion | Due to
Incorrect Active Ingredient | Lucky
Mart Inc. |
| 2/8/18 | Tetracycline-ABC, Tetrastem, Diabecline and
more | topical
products | Manufacturing
Practices | Phillips
Company |
| 2/8/18 | X-Gen | Ibuprofen
Lysine Injection, 20 mg/2 mL | Some of
the vials have been found to contain particulate matter | Exela
Pharma Sciences, LLC |
| 2/8/18 | The Green Herb | AL-ER-G
dietary supplement | Presence
of Ephedra Herb, an FDA banned ingredient | MusclMasster
LLC |
| 2/8/18 | Alvogen | Clindamycin
Injection USP | Due to
Lack of Sterility Assurance | Alvogen |
| 2/8/18 | Hospira, Inc. | 25%
Dextrose Injection, USP (Infant) | Due to
the Presence of Particulate Matter | Hospira,
Inc. |
| 2/8/18 | Synergy Rx Pharmacy | Non-sterile
drug products | Lack of
Quality Assurance | Synergy
Rx Pharmacy |
| 2/8/18 | Apexxx | Dietary
Supplement | Due to
presence of Sildenafil | Nuway
Distributors |
| 2/8/18 | ICU Medical, Inc. | 0.9%
Sodium Chloride Injection, USP 1000 mL | Due to
the Presence of Particulate Matter | ICU
Medical, Inc. |
| 2/8/18 | Fagron Sterile Services | Succinylcholine
Chloride 20mg/mL | Lack of
Sterility Assurance | Fagron
Sterile Services |
| 2/8/18 | Andropharm | Sten Z
and M1 Alphas capsules | Contain
derivatives of anabolic steroids | Andropharm |
| 2/8/18 | C.O. Truxton, Inc. | Phenobarbital
Tablets, USP, 15 mg | Due to
Labeling Error on Declared Strength | C.O.
Truxton, Inc. |
| 2/8/18 | LaBri’s Body Health | Dietary
Supplement | Due to
presence of Sibutramine | EZ
Weight Loss TX |
| 2/8/18 | Super Panther 7K | Dietary
Supplement | Unapproved
new drug | Ultra
Shop Supplement |
| 2/7/18 | PharMEDium | Potassium
Phosphate and Succinylcholine Chloride Intravia Bags | Due to
Lack of Sterility Assurance | PharMEDium
Services |
| 2/7/18 | Synergy Rx Pharmacy | Human
Chorionic Gonadotropin (HCG)for injection | Due to
Lack of Sterility Assurance | Synergy
Rx Pharmacy |
| 2/7/18 | Bristol-Myers Squibb | Eliquis
(apixaban) 5 mg Tablets | Labeling | Bristol-Myers
Squibb |
| 2/7/18 | Ultra-Sten, D-Zine | Marketed
as a dietary supplement | Unapproved
drugs | Hardcore
Formulations |
| 2/7/18 | Apace Packaging LLC | Cyclobenzaprine
HCl Tablet and Amantadine HCl Capsule | Cyclobenzaprine
HCL may contain Amantadine HCL Capsules | Apace
Packaging LLC |
| 2/7/18 | Isomeric Pharmacy Solutions | Multiple
compounded sterile products | Due to
Lack of Sterility Assurance | Isomeric
Pharmacy Solutions |
| 2/6/18 | Hospira | 8.4%
Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive
solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium
Phosphates Injection, USP | Due to
microbial growth | Hospira
Inc, A Pfizer Company |
| 2/6/18 | Advanced Pharma | Potassium
Phosphate and Succinylcholine Chloride | Due to
Lack of Sterility Assurance | Advanced
Pharma, Inc. d/b/a Avella of Houston |
| 2/6/18 | PharMEDium | Norepinephrine
Bitartrate added to Sodium Chloride | Found to
exhibit a slight discoloration in the admixture | PharMEDium
Services, LLC |
| 2/6/18 | Lupin | Mibelas
24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and
ferrous fumarate 75 mg) | Missing
Expiry | Lupin
Pharmaceuticals Inc. |
| 2/6/18 | Advanced Pharma | Nitroglycerin
products | Due To
Sub-Potency | Advanced
Pharma, Inc. d/b/a Avella of Houston |
| 2/6/18 | Teva Pharmaceuticals USA, Inc | Paliperidone
Extended-Release Tablets, 3mg | Due to
Dissolution Test Failure | Teva
Pharmaceuticals USA, Inc |
| 2/6/18 | Advanced Pharma | All
unexpired sterile injectable products labeled “latex free” that were produced
at Advanced Pharma, Inc.’s Houston location | Potential
Inaccuracy of Latex Free Label Reference | Avella
Specialty Pharmacy |
| 2/6/18 | HYDROmorphone, Levophed | Hydromorphone
HCl, Levophed | Due to
Lack of Sterility Assurance | Hospira,
Inc. |
| 2/6/18 | International Laboratories, LLC | Pravastatin
Sodium Tablets | Labeled
as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride
XL 300 mg tablets | International
Laboratories, LLC |
| 2/6/18 | Leader, Major, Rugby | Liquid
drug products | Possible
contamination | Cardinal
Health |
| 2/6/18 | Gericare | Sterile
Eye Irrigation Solution | Potential
microbial contamination which compromises sterility | Kareway
Products Inc. |
| 2/6/18 | PharMEDium | Oxytocin | Sub-Potency | PharMEDium
Services, LLC |
| 2/6/18 | Centurion | Ninjacof
and Ninjacof A | Potential
contamination with Burkholderia cepacia | Centurion
Labs
|
| 2/6/18 | Hospira, Inc. | Vancomycin
Hydrochloride for Injection | Due to
the Presence of Particulate Matter | Hospira,
Inc. |
| 2/6/18 | Atlantic Pharmacy and Compounding | All
compounded injectable prescription medications | Lack of
Sterility Assurance | Vital
Rx, Inc. d/b/a Atlantic Pharmacy and Compounding |
| 2/6/18 | Truxton Incorporated | Amitriptyline
HCL Tablets, USP 50mg andPhenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg | Label
Mix-up Error | C.O.
Truxton, Inc. |
| 2/6/18 | Caverflo | Natural
Herbal Coffee | Undeclared
Active Pharmaceutical Ingredients and Undeclared Milk | Caverflo.com |
| 1/29/18 | Limbrel | Limbrel,
Limbrel 250, Limbrel 500 | Due to
adverse event reports of elevated liver function tests or acute
hypersensitivity pneumonitis | Primus
Pharmaceuticals, Inc. |
| 1/25/18 | AuroMedics | Levofloxacin
in 5% Dextrose Injection 250mg/50mL | Due to
the Presence of Particulate Matter | AuroMedics
Pharma LLC |
| 1/24/18 | Basic Drugs | Senna
Laxative | Due to
Mislabeling | Magno-Humphries
Laboratories, Inc. |
| 1/16/18 | Nexterone | Nexterone
150mg/100ml injection | Due to
the Presence of Particulate Matter | Baxter
International Inc. |
| 1/16/18 | Nexterone | Amiodarone
HCl | Presence
of Particulate Matter | Baxter
International Inc |
| 1/11/18 | PharMEDium Services, LLC | Compounded
injectables | Lack of
Sterility | PharMEDium
Services, LLC |
| 1/11/18 | PharMEDium Services LLC | Various
compounded drug products intended to be sterile | Lack of
Sterility | PharMEDium
Services LLC |
| 1/10/18 | International Laboratories, LLC | Clopidogrel
Tablets USP, 75 mg | Due to
Mislabeling | International
Laboratories, LLC |
| 1/10/18 | AuroMedics Pharma LLC | Ampicillin
and Sulbactam for Injection USP | Presence
of Glass Particles in Vial | AuroMedics
Pharma LLC |
| 12/29/17 | Ridge Properties DBA Pain Relief Naturally | Pain and
itch relief products | Manufacturing
Concerns | Ridge
Properties DBA Pain Relief Naturally |
| 12/29/17 | Fresenius Kabi USA | Midazolam
Injection, USP prefilled syringe | Mislabeled | Fresenius
Kabi USA |
| 12/29/17 | Greenstone LLC | diphenoxylate
hydrochloride and atropine sulfate tablets, USP | Due to
Possible Sub Potent and Super Potent Tablets | Greenstone
LLC, a wholly owned subsidiary of Pfizer Inc. |
| 12/29/17 | Sun Pharma | Riomet®
(Metformin Hydrochloride Oral Solution), 500 mg/5mL | Microbial
Contamination (Scopulariopsis brevicaulis) | Sun
Pharmaceutical Industries Ltd |
| 12/29/17 | Pharmacist Choice | Alcohol
Prep Pads | Due to
Lack of Sterility Assurance | Simple
Diagnostics |
| 12/29/17 | Marmex Corp | Male
Enhancement | Unapproved
new drug | Marmex
Corp |
| 12/29/17 | AuroMedics Pharma LLC | Pantoprazole
Sodium for Injection 40 mg per vial | Contains
glass particles | AuroMedics
Pharma LLC |
| 12/29/17 | AuroMedics | Linezolid
Injection | White
particulate matter that has been identified as mold | AuroMedics
Pharma |
| 10/20/17 | SCA Pharmaceuticals LLC | Injectable
drugs | Lack of
Sterility Assurance | SCA
Pharmaceuticals LLC |
| 10/19/17 | A1 Slim | Dietary
Supplement A1 Slim | Unapproved
new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl
sibutramine | Kiriko,
LLC |
| 10/19/17 | A1 | Dietary
Supplement A1 Slim | Unapproved
new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl
sibutramine | Kiriko,
LLC |
| 10/5/17 | Baxter | INTRALIPID
20% IV Fat Emulsion, 100 mL | Product
exposed to subfreezing temperatures | Baxter
International Inc.
|