Drug recalls
627 recalls
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only
Aurobindo Pharma USA Inc
shortfill;
Cyclophosphamide for Injection, USP, 2 gram/vial
Sunny Pharmtech Inc.
Presence of Particulate Matter;
Cyclophosphamide for Injection, USP, 1 gram/vial
Sunny Pharmtech Inc.
Presence of Particulate Matter;
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Central Admixture Pharmacy Services Inc
Incorrect Product Formulation
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Dabigatran Etexilate Capsules, 150 mg
Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analy…
Dabigatran Etexilate Capsules, 75 mg
Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analy…
Dabigatran Etexilate Capsules, 75 mg
Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analy…
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described…
Mycophenolate Mofetil for Injection USP, 500 mg/Vial
MYLAN PHARMACEUTICALS INC
Presence of precipitate
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%
MICRO LABS USA INC
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg)
Major Pharmaceuticals
Subpotent Drug
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg)
Major Pharmaceuticals
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg)
Major Pharmaceuticals
Subpotent Drug
Xylocaine (lidocaine HCl Injection, USP), 1%
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10)
Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc…
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg
Bionpharma Inc.
Presence of Foreign Tablets/Capsules
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg)
Major Pharmaceuticals
Subpotent Drug
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle
JB Chemicals and Pharmaceuticals Ltd
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablet…
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg)
Major Pharmaceuticals
Subpotent Drug
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules
Supernus Pharmaceuticals, Inc.
Failed Dissolution Specifications
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only
Precision Dose Inc.
Failed Impurities/Degradation Specifications
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg)
Major Pharmaceuticals
Subpotent Drug
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL)
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg)
Major Pharmaceuticals
Subpotent Drug