Recalls / Class II
Class IID-072-2013
Product
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.
- 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
- a) 40 mg 90 count, Lot #s: 2434265, 2434266, 2434824, 2434826, 2434827, 2434828, 2434829, 2434830, 2434831, Exp 07/31/2014; 2436580, 2436725, 2436727, 2436729, 2437377, 2437380, 2437941, 2437943, 2437944, 2437949, 2437950, 2437955, Exp 08/31/2014. b) 40 mg 500 count, Lot #s: 2437956, 2437957, 2440675, 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
- 157,026 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-072-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.