PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 2, 2023 Initiated: June 23, 2023 #D-0942-2023

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

Reason for Recall

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

Details

Recalling Firm
Kramer Laboratories, Inc.
Units Affected
N/A
Distribution
nationwide within the United States
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Kramer Laboratories, Inc.. Units affected: N/A.
Why was this product recalled?
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 2, 2023. Severity: Moderate. Recall number: D-0942-2023.