Denison Pharmaceuticals, LLC Provisional
FDA Flags (8)
Class II RecallMar 2025
Denison Pharmaceuticals, LLC
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA
Classification: Class II
Class III RecallNov 2024
Denison Pharmaceuticals, LLC
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur
Classification: Class III
Class III RecallNov 2024
Denison Pharmaceuticals, LLC
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt
Classification: Class III
Class II RecallJun 2024
Denison Pharmaceuticals, LLC
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte
Classification: Class II
Class II RecallJun 2023
Denison Pharmaceuticals, LLC
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Inc
Classification: Class II
Class II RecallJun 2023
Denison Pharmaceuticals, LLC
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118
Classification: Class II
Class II RecallJun 2023
Denison Pharmaceuticals, LLC
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota
Classification: Class II
Class II RecallJun 2023
Denison Pharmaceuticals, LLC
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle
Classification: Class II