D-0772-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2023
- Initiation Date
- May 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86,616 4 OZ bottles
Product Description
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.
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Distribution Pattern
Product was distributed Nationwide.
Code Information
Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023