Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of Assurance of Sterility.
FDA Drug Recalls
166 recalls, newest first
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II · Moderate risk
Vasopressin Injection
Subpotent product in addition to having out-of-specification results for impurities.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Defective container: lack of seal integrity.
Class II · Moderate risk
TraMADol HCl 50 mg Tablet
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 125 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 250 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
minolira (minocycline hydrochloride)
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
minolira (minocycline hydrochloride)
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
Cloderm (clocortolone pivalate)
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 I · High risk
Schwinnng Herbal Dietary Supplement Capsules
Marketed Without An Approved NDA/ANDA
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class III · Low risk
Digoxin Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of assurance of sterility: bags have the potential to leak..
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations