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.
Reported: June 7, 2023 Initiated: May 3, 2023 #D-0772-2023
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.
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Details
- Recalling Firm
- Denison Pharmaceuticals, LLC
- Units Affected
- 86,616 4 OZ bottles
- Distribution
- Product was distributed Nationwide.
- Location
- Lincoln, RI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Denison Pharmaceuticals, LLC. Units affected: 86,616 4 OZ bottles.
Why was this product recalled? ▼
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0772-2023.
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