Drug Enforcement D-071-2013

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

Status

Terminated

Classification

Class II

Report Date

December 5, 2012

Termination Date

April 28, 2014

Product Information

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
Product quantity
203,198 Bottles
Reason for recall
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide and PR

Location & Firm

Recalling firm
Ranbaxy Inc.
Address
600 College Rd E Ste 2100, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-071-2013
Event ID
63759
Recall initiation date
November 9, 2012
Center classification date
November 29, 2012
Code info
Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.
More code info
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