ALLERGAN recalls NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by…

Recall date

February 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0413-2018

FDA classification

Class III

Brand / firm

ALLERGAN

Sold / distributed

Nationwide in the USA

Why it was recalled

Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.