D-0775-2023 Class II Ongoing
FDA drug recall D-0775-2023 was initiated by Denison Pharmaceuticals, LLC on May 3, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Use of non-food grade lubricant in mixing vessel. The recall status is ongoing. Affected quantity: 13,968 bottles.
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
- 13,968 bottles
Product Description
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.
Distribution Pattern
Product was distributed Nationwide.
Code Information
Lot 8639, Exp: 8/2023