PlainRecalls
FDA Drug Moderate Class II Terminated

Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90

Reported: December 5, 2012 Initiated: November 9, 2012 #D-071-2013

Product Description

Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90

Reason for Recall

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

Details

Recalling Firm
Ranbaxy Inc.
Units Affected
203,198 Bottles
Distribution
Nationwide and PR
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90. Recalled by Ranbaxy Inc.. Units affected: 203,198 Bottles.
Why was this product recalled?
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-071-2013.