FDAFDA · Food and drugs·Recall number D-1607-2014
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
Published October 1, 2014 · Recall initiated: August 28, 2014
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
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alvogen, Inc
- Distributor
- Nationwide
- Lot
- NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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