FDA recall D-1443-2012

Apotex Corp. · Class II · drug

Product

Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.

Reason for recall

Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-04-05
Report date: 2012-08-15
Termination date: 2013-09-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1443-2012