Drug 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.
D-0775-2023
Product summary
- Event
- Event 92268
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,968 bottles
- Official record key
drug-enforcement:D-0775-2023
Official wording
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Code information: Lot 8639, Exp: 8/2023
Distribution pattern: Product was distributed Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations