FDAFDA · Food and drugs·Recall number D-0775-2023
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Published June 7, 2023 · Recall initiated: May 3, 2023
Status when published: Ongoing — 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
- Denison Pharmaceuticals, LLC
- Distributor
- Product was distributed Nationwide.
- Lot
- Lot 8639, Exp: 8/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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