FDA recall D-0413-2018

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-02-02

Report date

2018-02-21

Termination date

2019-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2018