FDA recall D-0007-2018

Product

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

Reason for recall

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

Distribution

CO, OH

Key facts

Status

Terminated

Initiation date

2017-09-22

Report date

2017-10-18

Termination date

2018-04-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danbury, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2018