Drug recalls
627 recalls
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Xylocaine (lidocaine HCl Injection, USP), 1%
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg)
Major Pharmaceuticals
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg)
Major Pharmaceuticals
Subpotent Drug
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL)
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)
Major Pharmaceuticals
Subpotent Drug
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP
Asclemed USA Inc.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg
Ascend Laboratories, LLC
Failed Dissolution Specifications;
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg)
Major Pharmaceuticals
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg)
Major Pharmaceuticals
Subpotent Drug
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL
Rising Pharma Holding, Inc.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10)
Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc…
Papaverine Hydrochloride Injection, USP 60 mg/2 mL
American Regent, Inc.
Products were found to contain particulate matter.
Baxter Cefazolin in Dextrose Injection
Baxter International Inc.
Particulate matter identified as cardboard was found in the solution.
Long Grove Pharmaceuticals Cyclophosphamide for Injection
Sunny Pharmtech, Inc. (Long Grove Pharmaceuticals)
Presence of particulate matter identified as steel.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g
Padagis US LLC
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
QC Quality Choice, Carbamide Peroxide, 6.5%
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL)
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL)
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL)
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Pero…
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL)
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL)
Chiesi USA, Inc.
Lack of Assurance of Sterility
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70%…
CareFusion 213, LLC
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa…
TopCare Health, CARBAMIDE PEROXIDE 6.5%
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).