Recalls / Class III
Class IIID-823-2013
Product
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.
- Affected lot / code info
- Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
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.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, N/A, Corona, California 92880-1724
Distribution
- Quantity
- 1,260 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-19
- FDA classified
- 2013-07-25
- Posted by FDA
- 2013-07-31
- Terminated
- 2014-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-823-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.