FDA Recall D-0775-2023
Denison Pharmaceuticals, LLC · Lincoln, RI
Class II Ongoing 1107 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Recall record
- Recall number
D-0775-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed Nationwide.
- Recall initiated
- 2023-05-03
- Classified by FDA Center
- 2023-05-31
- FDA published
- 2023-06-07
- Recalling firm
- Denison Pharmaceuticals, LLC
- Firm location
- Lincoln, RI
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.