Recalls / Class II
Class IID-070-2013
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
- 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
- Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.
Why it was recalled
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recalling firm
- Firm
- Ranbaxy Inc.
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 2100, N/A, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 120,201 Bottles
- Distribution pattern
- Nationwide and PR
Timeline
- Recall initiated
- 2012-11-09
- FDA classified
- 2012-11-29
- Posted by FDA
- 2012-12-05
- Terminated
- 2014-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-070-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.