D-0413-2018 Class III Terminated
FDA drug recall D-0413-2018 was initiated by ALLERGAN on Feb 2, 2018 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label. The recall status is terminated (terminated Feb 7, 2019). Affected quantity: 8 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Feb 2, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0413-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026