Drug & medication recalls Moderate risk

Safe Tussin DM Cough + Chest Congestion recalled over manufacturing violations

Recall date
June 23, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Kramer Laboratories, Inc. recalls Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in…
Recall number
D-0942-2023
FDA classification
Class II
Brand / firm
Kramer Laboratories, Inc.
Sold / distributed
nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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