FDA recall D-0599-2018

Product

Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-03-21

Termination date

2020-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018