Kramer Laboratories, Inc.: Drug Recall

Recall #D-0942-2023 · 06/23/2023

Class II: Risk

Recall Details

Recall Number
D-0942-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Kramer Laboratories, Inc.
Status
Terminated
Date Initiated
06/23/2023
Location
Bridgewater, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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

Distribution Pattern

nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.