Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Buprenorphine HCl Injection
Reason Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason 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 Terminated
BusPIRone Hydrochloride Tablets
Reason Failed Impurity /Degradation Specifications
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason 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 Terminated
Prednisone Tablets
Reason 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 Terminated
Just Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
Always Be Clean Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
UltraCruz Hand Sanitizing Gel Antimicrobial
Reason Subpotent drug
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk Terminated
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ketamine 50 mg Infusion
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Reason Lack of Assurance of Sterility