Class III
Terminated
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.
This recall has been terminated (originally issued July 31, 2013).
- Company
- Watson Laboratories Inc
- Recall Initiated
- July 19, 2013
- Posted
- July 31, 2013
- Recall Number
- D-823-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,260 bottles
- Firm Location
- Corona, CA, United States
- Official Source
- View on FDA website ↗
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
Nationwide
Lot / Code Info
Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
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