PlainRecalls
FDA Drug Moderate Class II Terminated

Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90

Reported: March 5, 2014 Initiated: January 16, 2014 #D-1086-2014

Product Description

Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90

Reason for Recall

Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Details

Recalling Firm
Ranbaxy Inc.
Units Affected
64,626 bottles
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90. Recalled by Ranbaxy Inc.. Units affected: 64,626 bottles.
Why was this product recalled?
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 5, 2014. Severity: Moderate. Recall number: D-1086-2014.