Recalls / Class II
Class IID-0775-2023
Product
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
- Affected lot / code info
- Lot 8639, Exp: 8/2023
Why it was recalled
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Recalling firm
- Firm
- Denison Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Powder Hill Rd, N/A, Lincoln, Rhode Island 02865-4407
Distribution
- Quantity
- 13,968 bottles
- Distribution pattern
- Product was distributed Nationwide.
Timeline
- Recall initiated
- 2023-05-03
- FDA classified
- 2023-05-31
- Posted by FDA
- 2023-06-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0775-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.