Drug product
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
D-0772-2023
Product summary
- Event
- Event 92268
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 86,616 4 OZ bottles
- Official record key
drug-enforcement:D-0772-2023
Official wording
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Code information: Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
Distribution pattern: Product was distributed Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations