Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
-
Class I · 3 months ago
Sunny Pharmtech Inc. Cyclophosphamide for Injection, USP, 1 gram/vial recall: Presence of Particulate Matter; identified as stainless steel
Presence of Particulate Matter; identified as stainless steel
-
Class II · 3 months ago
Zydus Pharmaceuticals Inc Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle recall: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
-
Class III · 3 months ago
Central Admixture Pharmacy Services Inc Total Parental Nutrition - Pediatric PN recall: Incorrect Product Formulation
Incorrect Product Formulation
-
Class I · 3 months ago
Sunny Pharmtech Inc. Cyclophosphamide for Injection, USP, 2 gram/vial recall: Presence of Particulate Matter; identified as stainless steel
Presence of Particulate Matter; identified as stainless steel
-
Class II · 3 months ago
Aurobindo Pharma USA Inc Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles recall: shortfill; reports of empty capsules
shortfill; reports of empty capsules.
-
Class III · 3 months ago
Ascend Laboratories, LLC Dabigatran Etexilate Capsules, 150 mg recall: Failed impurity/degradation specification: an OOS result observed in Related
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
-
Class II · 3 months ago
Micro Labs USA Inc Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP recall: Defective Container: Firm received multiple complaints of broken cap spikes
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
-
Class II · 3 months ago
Mylan Pharmaceuticals Inc Mycophenolate Mofetil for Injection USP, 500 mg/Vial recall: Presence of precipitate
Presence of precipitate
-
Class II · 3 months ago
Glenmark Pharmaceuticals Inc., USA Azelaic Acid Gel, 15%, 50 gram tubes recall: CGMP Deviations: Product quality complaints concerning abnormal texture
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
-
Class III · 3 months ago
Ascend Laboratories, LLC Dabigatran Etexilate Capsules, 75 mg recall: Failed impurity/degradation specification: an OOS result observed in Related
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
-
Class III · 3 months ago
Ascend Laboratories, LLC Dabigatran Etexilate Capsules, 75 mg recall: Failed impurity/degradation specification: an OOS result observed in Related
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
-
Class II · 3 months ago
Rohto-Mentholatum Co., Ltd. Rohto Cooling Eye Drops Dry Aid , Sterile recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class II · 3 months ago
Major Pharmaceuticals Levothyroxine Sodium Tablets, USP, 150 mcg recall: Subpotent Drug
Subpotent Drug
-
Class II · 3 months ago
Rohto-Mentholatum Co., Ltd. Rohto Cooling Eye Drops ALL-IN-ONE , Sterile 0.4 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class III · 3 months ago
Ascend Laboratories, LLC Dabigatran etexilate Capsules, 110 mg, 60-count carton recall: Failed Impurities/Degradation Specifications: OOS result was observed during
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
-
Class I · 3 months ago
JB Chemicals and Pharmaceuticals Ltd Cetirizine Hydrochloride Tablets USP 5 mg recall: Cross Contamination with Other Products: Customer complaints for appearance
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
-
Class II · 3 months ago
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL recall: Presence of Precipitate: medication was crystallizing and particles floating
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
-
Class II · 3 months ago
Major Pharmaceuticals Levothyroxine Sodium Tablets, USP, 50 mcg recall: Subpotent Drug
Subpotent Drug
-
Class II · 3 months ago
Precision Dose Inc. Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
-
Class II · 3 months ago
Major Pharmaceuticals Levothyroxine Sodium Tablets, USP, 125 mcg recall: Subpotent Drug
Subpotent Drug
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Glycopyrrolate Injection, USP, 1 mg per 5 mL recall: Presence of Particulate Matter: Hair was found in product
Presence of Particulate Matter: Hair was found in product
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Xylocaine , 1%, 500 mg per 50 mL , 25 Multiple-Dose Vials recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
-
Class II · 3 months ago
Rohto-Mentholatum Co., Ltd. Rohto Cooling Eye Drops Optic Glow , Sterile, 0.4 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class II · 3 months ago
Major Pharmaceuticals Levothyroxine Sodium Tablets, USP, 112 mcg recall: Subpotent Drug
Subpotent Drug