FDA recall D-0836-2018

Product

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

Reason for recall

Labeling: Missing Label

Distribution

OH

Key facts

Status

Terminated

Initiation date

2018-05-24

Report date

2018-06-06

Termination date

2021-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0836-2018