Drug 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.
D-072-2013
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 63759
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157,026 Bottles
- Official record key
drug-enforcement:D-072-2013
Official wording
Reason: Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Code information: 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.
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter