Class III · Low risk Terminated
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx…
Reason CGMP Deviations: Cylinders filled using out of date gauges.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use…
Class III · Low risk Terminated
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505…
Reason Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk Terminated
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus…
Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC…
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637…
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles…
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus…
Reason Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for…
Class III · Low risk Terminated
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad…
Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Class III · Low risk Terminated
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx…
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only…
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only…
Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk Terminated
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and…
Reason Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk Terminated
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage…
Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk Terminated
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured…
Reason Defective Delivery System: Product may contain leaking capsules.
Class III · Low risk Terminated
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Reason Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class III · Low risk Terminated
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Reason Failed Impurities/Degradation Specifications; Impurity A