Class II · Moderate risk Terminated
Clobazam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Clobazam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Heparin Sodium
Reason Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class II · Moderate risk Terminated
Heparin Sodium Injection
Reason Labeling: Not elsewhere classified
Class II · Moderate risk Terminated
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Activator Concentrate
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Nose Better Gel
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Soltice Quick-RUB
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Unguentine Original Ointment for Burns
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Vencedor medicated balm
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Alcolado Relampago
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Clear Eyes
Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk Ongoing
NaturalCare
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NatraBio
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Terminated
Carbidopa and Levodopa Tablets
Reason Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason CGMP Deviations: Potential product carryover.
Class II · Moderate risk Terminated
Metformin hydrochloride Extended-Release Tablets
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility