Why it was recalled
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Product description
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
Lot numbers, UPCs & expiration codes
Lot # 544821A, Exp 07/19
Where it was sold
Nationwide in the USA
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-0413-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 8 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALLERGAN
Original FDA data
Every field from FDA enforcement report D-0413-2018, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79080
- Address
- 1 Giralda Farms
- Code information
- Lot # 544821A, Exp 07/19
- Postal code
- 07940-1027
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0413-2018
- Classification
- Class III
- Recalling firm
- ALLERGAN
- Product quantity
- 8 bottles
- Termination date
- Feb 7, 2019
- Reason for recall
- Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2018