Why it was recalled
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Product description
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Lot numbers, UPCs & expiration codes
Lot #: 519406A, 521759A, Exp 04/14
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-058-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 21, 2012
- FDA report date
- Nov 28, 2012
- Quantity
- 4,874 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-058-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63246
- Address
- 311 Bonnie Cir
- Code information
- Lot #: 519406A, 521759A, Exp 04/14
- Postal code
- 92880-2882
- Report date
- Nov 28, 2012
- Product type
- Drugs
- Recall number
- D-058-2013
- Classification
- Class I
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 4,874 bottles
- Termination date
- Mar 24, 2014
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 21, 2012
- Initial firm notification
- Press Release
- Center classification date
- Nov 16, 2012