D-823-2013 Class III Terminated
FDA drug recall D-823-2013 was initiated by Watson Laboratories Inc on July 19, 2013 and is designated Class III. 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 po… The recall status is terminated (terminated July 29, 2014). Affected quantity: 1,260 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- July 19, 2013
- Termination Date
- July 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,260 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13