LUPIN SOMERSET recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel L…

Recall date

May 24, 2018

Source

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

Recall number

D-0836-2018

FDA classification

Class III

Brand / firm

LUPIN SOMERSET

Sold / distributed

OH

Why it was recalled

Labeling: Missing Label

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

What was recalled

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102