Status
Terminated
Drug Enforcement D-060-2013
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.
Classification
Class II
Report Date
November 28, 2012
Termination Date
March 6, 2014
Product Information
- 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
- Product quantity
- 32,208 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
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-060-2013
- Event ID
- 63623
- Recall initiation date
- August 21, 2012
- Center classification date
- November 21, 2012
- Code info
- Lot #: 2407258, Exp 05/14
- More code info
- —