Safe Tussin PM Night Time Cough Relief 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 PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer…
- Recall number
- D-0943-2023
- 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 PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
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