Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
FDA Drug Recalls
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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 III · Low risk Completed
Valacyclovir Tablets USP
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
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 III · Low risk Terminated
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Reason Subpotent drug
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 III · Low risk Ongoing
Xelpros
Reason Failed Release Testing: Out of specification for particulate matter test.
Class I · High risk Terminated
Schwinnng Herbal Dietary Supplement Capsules
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution
Reason Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
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.