Class I - Dangerous
Failed Impurities/Degradation Specifications
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Dissolution Specifications
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Sagent Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Sagent Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Qualitest Pharmaceuticals
Class I - Dangerous
Failed tablet specifications: One lot was found to contain oversized tablets.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Class I - Dangerous
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class I - Dangerous
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.