Status
Terminated
Drug Enforcement D-0943-2023
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Classification
Class II
Report Date
August 2, 2023
Termination Date
March 12, 2024
Product Information
- Product description
- Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- nationwide within the United States
Location & Firm
- Recalling firm
- Kramer Laboratories, Inc.
- Address
-
440 Us Highway 22 Ste 210, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0943-2023
- Event ID
- 92407
- Recall initiation date
- June 23, 2023
- Center classification date
- July 24, 2023
- Code info
- Lot #: 8639, Exp. Date 8/2023
- More code info
- —