Class II · Moderate risk Ongoing
DermaCerin
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
4-N-1 Skin Protectant
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Irrigation USP. Isotonic Solution for Irrigation
Reason Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II · Moderate risk Ongoing
Sterile Water for Injection USP
Reason Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.
Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.
Class II · Moderate risk Ongoing
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50…
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk Ongoing
Ultra Violette
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL
Reason Discoloration
Class II · Moderate risk Ongoing
Carvedilol Tablets USP
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Completed
Dextroamphetamine Saccharate
Reason Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Reason Temperature Abuse
Class II · Moderate risk Ongoing
Tavaborole Topical Solution 5%
Reason Discoloration
Class II · Moderate risk Terminated
Lisdexamfetamine Dimesylate Capsules
Reason Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Theophylline extended-release tablets 400mg
Reason Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.