Recalls / Class II

Class IID-0772-2023

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.

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Denison Pharmaceuticals, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Powder Hill Rd, N/A, Lincoln, Rhode Island 02865-4407

Distribution

Quantity

86,616 4 OZ bottles

Distribution pattern

Product was distributed Nationwide.

Timeline

Recall initiated

2023-05-03

FDA classified

2023-05-31

Posted by FDA

2023-06-07

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0772-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.