Status
Terminated
Drug Enforcement D-823-2013
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.
Classification
Class III
Report Date
July 31, 2013
Termination Date
July 29, 2014
Product Information
- 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.
- Product quantity
- 1,260 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Watson Laboratories Inc
- Address
-
132 Business Center Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-823-2013
- Event ID
- 65747
- Recall initiation date
- July 19, 2013
- Center classification date
- July 25, 2013
- Code info
- Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
- More code info
- —