Drug product
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
D-0942-2023
Product summary
- Event
- Event 92407
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0942-2023
Official wording
Reason: CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Code information: Lot #: 8753, 8753A, Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023
Distribution pattern: nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations