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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Watson Laboratories Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-823-2013
Related Recalls
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.