Class II · Moderate risk Terminated
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated…
Reason CGMP Deviations: Released product should have been rejected.
Safe tussin PM
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
What was recalled
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.
- Recalling firm
- Denison Pharmaceuticals, LLC
- Origin
- RI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0775-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dextromethorphan recalls
See all
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
Adult Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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