Cough medicine recalled due to manufacturing process deviation with non-food lubricant
Denison Pharmaceuticals is recalling Safe tussin DM DAY TIME Cough Relief due to use of non-food grade lubricant in the manufacturing process. Approximately 86,616 bottles were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall was classified as FDA Class II, indicating potential health risk. The hazard is a documented manufacturing process deviation involving non-food grade lubricant in a drug mixing vessel. Although no illnesses or injuries have been reported, the violation of Current Good Manufacturing Practice standards qualifies this as a risk-of-harm scenario without yet-reported injury, meeting the criteria for High severity.
Plain-English summary
Denison Pharmaceuticals, LLC is recalling Safe tussin DM, DAY TIME Cough Relief (Dextromethorphan HBr 10mg, Guaifenesin 100mg) in 4 FL OZ bottles due to a manufacturing process deviation. The U.S. Food and Drug Administration classified this as a Class II recall.
A non-food grade lubricant was used in the mixing vessel during the manufacturing process, which constitutes a deviation from Current Good Manufacturing Practice (CGMP) requirements. The recalled product was distributed nationwide, with approximately 86,616 bottles affected across lot numbers 8314 (Exp 04/2023), 8753 and 8753A (Exp 10/2023), and 8659 (Exp 08/2023).
Consumers who have purchased this product should stop using it and dispose of it appropriately. Those with concerns should consult their healthcare provider.
The recalled product
- Product
- 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.
- Manufacturer
- Denison Pharmaceuticals, LLC
- Hazard
- manufacturing-contamination
- non-food-grade-lubricant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot: 8314
- Exp: 04/2023
- 8753
- 8753A
- Exp: 10/2023
- 8659
- Exp: 08-2023
Distribution
Distributed nationwide across the United States.
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