Class II · Moderate risk Completed
Cardura XL
Reason Failed Impurities/Degradation Specifications
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Completed
Cardura XL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
traMADol Hydrochloride Tablets
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk Ongoing
MethylPREDNISolone Acetate Injectable Suspension
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk Terminated
Timolol Maleate Ophthalmic Solution
Reason Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class II · Moderate risk Completed
Progesterone 200 mg
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk Ongoing
Haloperidol decanoate Injection 50mg/mL
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP 125 mg/5 mL
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP 250 mg/5 mL
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Terminated
Eylea
Reason Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk Terminated
minolira
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
minolira
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
Cloderm
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Ongoing
Amphotericin B Liposome for Injection
Reason Out of specification for assay
Class II · Moderate risk Ongoing
Ful-Glo
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
Ful-Glo
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
GloStrips
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
GloStrips
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk Ongoing
Aloe Gator
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.