D-0943-2023 Class II Terminated
FDA drug recall D-0943-2023 was initiated by Kramer Laboratories, Inc. on June 23, 2023 and is designated Class II. Reason for recall: CGMP Deviations: use of non-food grade lubricant in mixing vessel. The recall status is terminated (terminated March 12, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2023
- Initiation Date
- June 23, 2023
- Termination Date
- March 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
Reason for Recall
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Distribution Pattern
nationwide within the United States
Code Information
Lot #: 8639, Exp. Date 8/2023