Recalls / Class II
Class IID-1086-2014
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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 63304-827, 63304-828, 63304-829, 63304-830
- FDA application
- ANDA076477
- Affected lot / code info
- 2407255, 2407256 Exp. 05/14
Why it was recalled
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.
Recalling firm
- Firm
- Ranbaxy Inc.
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 2100, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 64,626 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-16
- FDA classified
- 2014-02-21
- Posted by FDA
- 2014-03-05
- Terminated
- 2015-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1086-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.