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.

FDA recall notice · announced July 31, 2013 · Watson Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

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.

Notes

Distribution: Nationwide
Lot/code information: Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
Quantity: 1,260 bottles
Status: Terminated
Products in this recall event:
- 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., Cor (D-823-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.