FDAFDA · Food and drugs·Recall number D-1064-2013
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
Published October 9, 2013 · Recall initiated: August 8, 2013
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: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Marlex Pharmaceuticals, Inc.
- Distributor
- Nationwide.
- Lot
- Lot #: 3213, Exp 12/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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