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Recall Observatory FDA recall evidence

Drug 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.

D-0772-2023

May 03, 2023

Class II

Product summary

Firm
Denison Pharmaceuticals, LLC
Event
Event 92268
Status
Ongoing
Classification
Class II
Quantity
86,616 4 OZ bottles
Official record key
drug-enforcement:D-0772-2023

Official wording

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Code information: Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023

Distribution pattern: Product was distributed Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations