FDAFDA · Food and drugs·Recall number D-823-2013
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
Published July 31, 2013 · Recall initiated: July 19, 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
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Watson Laboratories Inc
- Distributor
- Nationwide
- Lot
- Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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