Drug product
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
D-0943-2023
Product summary
- Event
- Event 92407
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0943-2023
Official wording
Reason: CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Code information: Lot #: 8639, Exp. Date 8/2023
Distribution pattern: nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations