Drug product
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
D-070-2013
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 63759
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120,201 Bottles
- Official record key
drug-enforcement:D-070-2013
Official wording
Reason: Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Code information: Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter