Class II · Moderate risk
aulief (Organic Camphor 3.00% Organic Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
FDA Drug Recalls
84 recalls, newest first
Class II · Moderate risk
China-Gel White
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Class II · Moderate risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class I · High risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level