D-0413-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- February 2, 2018
- Termination Date
- February 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 bottles
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.
Reason for Recall
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 544821A, Exp 07/19