Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-823-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 19, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 1,260 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-823-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 65747
- Address
- 132 Business Center Dr
- Code information
- Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
- Postal code
- 92880-1724
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-823-2013
- Classification
- Class III
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 1,260 bottles
- Termination date
- Jul 29, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2013