Drug 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.
D-823-2013
Product summary
- Event
- Event 65747
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,260 bottles
- Official record key
drug-enforcement:D-823-2013
Official wording
Reason: 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.
Code information: Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent