Brand
Denison Pharmaceuticals, LLC
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Denison Pharmaceuticals, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-19FDA-DrugClass IIZapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Chemical Contamination: Presence of benzene.
- 2024-11-13FDA-DrugClass IIIKids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- 2024-11-13FDA-DrugClass IIIAdult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- 2024-06-26FDA-DrugClass IILittle Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
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