Reported Jul 31, 2013 · Terminated
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count…
Watson Laboratories Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Watson Laboratories Inc · 132 Business Center Dr · Corona, CA · 92880-1724
Is this the product you have?
- 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.
- Lot codes and dates
Lot # a) 444971AExp 8/13b) 444973AExp 8/13
- Amount recalled
- 1,260 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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