Drug recall D-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.
Reason for recall
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Lots and codes
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.
Recall details
- Recalling firm
- Ranbaxy Inc., Princeton, NJ
- Quantity
- 157,026 Bottles
- Distribution
- Nationwide and PR
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 9, 2012
- Terminated
- April 28, 2014
Related products
- Atorvastatin Calcium – drug information
- NDC 63304-829 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 40 mg/1 · Sun Pharmaceutical Industries Inc.
- NDC 63304-830 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 80 mg/1 · Sun Pharmaceutical Industries Inc.