Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Ph...
FDA Recall #D-070-2013 — Class II — November 9, 2012
Product Description
Atorvastatin Calcium Tablets, 10 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 #: 63304-827-90
Reason for Recall
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recalling Firm
Ranbaxy Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
120,201 Bottles
Distribution
Nationwide and PR
Code Information
Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated