Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Heparin Sodium
Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk
Heparin Sodium Injection
Labeling: Not elsewhere classified
Class III · Low risk
Colchicine Tablets
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class II · Moderate risk
Class II · Moderate risk
Activator Concentrate
CGMP DEVIATIONS
Class II · Moderate risk
Nose Better Gel
CGMP DEVIATIONS
Class II · Moderate risk
Soltice Quick-RUB
CGMP DEVIATIONS
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Vencedor medicated balm
CGMP DEVIATIONS
Class II · Moderate risk
Alcolado Relampago
CGMP DEVIATIONS
Class III · Low risk
Fentanyl 1
Subpotent Drug
Class II · Moderate risk
Clear Eyes
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem HCl in 0.7% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl 20 mg
CGMP DEVIATIONS