Why it was recalled
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Product description
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
Lot numbers, UPCs & expiration codes
Lot #: 697316A, Expiry: Mar 2015.
Where it was sold
Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
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-1053-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2014
- FDA report date
- Feb 5, 2014
- Quantity
- 717 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1053-2014, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 67348
- Address
- 132 Business Center Dr
- Code information
- Lot #: 697316A, Expiry: Mar 2015.
- Postal code
- 92880-1724
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1053-2014
- Classification
- Class II
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 717 bottles
- Termination date
- Jul 25, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications; Product contains broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
- Distribution pattern
- Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
- Recall initiation date
- Jan 15, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2014