Class I - Dangerous
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.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
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 I - Dangerous
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.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Pyramids Wholesale
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
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.
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
Specialty Process Labs
Class I - Dangerous
Failed Stability Specifications
Class I - Dangerous
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I - Dangerous
CGMP Deviations
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
Specialty Process Labs
Class I - Dangerous
Failed Stability Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Amneal Pharmaceuticals of New York
Class I - Dangerous
Superpotent Drug: Due to overfilling of drug powder
Class I - Dangerous
CGMP Deviations
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Teva Pharmaceuticals USA
Class I - Dangerous
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
Subpotent Drug
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
IntegraDose Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility: leaking bags