Status
Ongoing
Drug Enforcement D-0772-2023
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Classification
Class II
Report Date
June 7, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 86,616 4 OZ bottles
- Reason for recall
- CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed Nationwide.
Location & Firm
- Recalling firm
- Denison Pharmaceuticals, LLC
- Address
-
1 Powder Hill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0772-2023
- Event ID
- 92268
- Recall initiation date
- May 3, 2023
- Center classification date
- May 31, 2023
- Code info
- Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
- More code info
- —