Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II · Moderate risk
Empower Pharmacy
Lack of Assurance of Sterility
Class II · Moderate risk
Gabapentin Tablets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Cyanocobalamin Injection
Presence of particulate matter: glass
Class II · Moderate risk
Potassium Chloride Micro 10mEq K
CGMP Deviations: Out of specification for dissolution
Class II · Moderate risk
Blemfree All Day Lotion
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk
Venlafaxine Hydrochloride
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class II · Moderate risk
Phenazopyridine HCl
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Petroleum Jelly
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II · Moderate risk
Vasopressin Injection
Subpotent product in addition to having out-of-specification results for impurities.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Defective container: lack of seal integrity.
Class II · Moderate risk
TraMADol HCl 50 mg Tablet
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol