FDA recall D-1150-2022

Product

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

Reason for recall

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Distribution

Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.

Key facts

Status

Terminated

Initiation date

2022-06-10

Report date

2022-06-22

Termination date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1150-2022