Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II · Moderate risk
Carbamazepine Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
Class II · Moderate risk
edunn clarity
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
Micronized BPO Gel Cleanser 10%
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
mel rx Skin
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
Skin MD by Dr Monika Kiripolsky
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
Artisan of Skin
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Mertiatide
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit