FDA recall D-072-2013

Ranbaxy Inc. · Class II · drug

Product

Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.

Reason for recall

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Distribution

Nationwide and PR

Key facts

Status: Terminated
Initiation date: 2012-11-09
Report date: 2012-12-05
Termination date: 2014-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-072-2013