FDAFDA · Food and drugs·Recall number D-0943-2023
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Published August 2, 2023 · Recall initiated: June 23, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kramer Laboratories, Inc.
- Distributor
- nationwide within the United States
- Lot
- Lot #: 8639, Exp. Date 8/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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