← FDA ENFORCEMENT
D-0942-2023Class II

Kramer Laboratories, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Kramer Laboratories, Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-02
Distribution
nationwide within the United States
Firm state
NJ
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Code / lot info

Lot #: 8753, 8753A, Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →