Why it was recalled
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Product description
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
Lot numbers, UPCs & expiration codes
Lot 706224A and 706225A, Exp. 04/15.
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-1061-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 30, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1061-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66169
- Address
- 132 Business Center Dr
- Code information
- Lot 706224A and 706225A, Exp. 04/15.
- Postal code
- 92880-1724
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1061-2013
- Classification
- Class III
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 875 bottles
- Termination date
- Jul 25, 2014
- Reason for recall
- Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 30, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 17, 2013