Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Buprenorphine HCl Injection
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk
Prednisone Tablets
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk
Elitek (rasburicase)
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II · Moderate risk
Just Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
Always Be Clean Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
UltraCruz Hand Sanitizing Gel Antimicrobial
Subpotent drug
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Lack of Assurance of Sterility
Class II · Moderate risk
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50 mg Infusion
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility