Drug product
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
D-060-2013
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 63623
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,208 bottles
- Official record key
drug-enforcement:D-060-2013
Official wording
Reason: Adulterated 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.
Code information: Lot #: 2407258, Exp 05/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets