FDARecalled Jun 7, 2023 · #D-0775-2023
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Hazard
Class II — temporary health risk
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CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Classification: Class II Distribution: Product was distributed Nationwide.
Product details
- Product
- Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
- Type
- Drugs
- Manufacturer
- Denison Pharmaceuticals, LLC
- Model numbers
- 8639
- UPCs
- —