Class III · Low risk Ongoing
Mektovi
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Calcitonin Salmon Nasal Spray
Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class II · Moderate risk Terminated
Clobazam Tablets
Reason CGMP Deviations: Potential risk of Cross Contamination
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 I · High risk Ongoing
Delsam Pharma's Artificial Eye Ointment
Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class III · Low risk Terminated
Colchicine Tablets
Reason 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 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 III · Low risk Terminated
Fentanyl 1
Reason Subpotent Drug
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.