Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ranbaxy Inc., originally initiated on 11-09-2012 for the product Atorvastatin Calcium Tablets, 20 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 #: 63304-828-90 The product was recalled due to presence of particulate matter: certain batches of atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-071-2013 | 11-09-2012 | 12-05-2012 | Class II | 203,198 Bottles | Atorvastatin Calcium Tablets, 20 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 #: 63304-828-90 | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| D-070-2013 | 11-09-2012 | 12-05-2012 | Class II | 120,201 Bottles | 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 | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
| D-072-2013 | 11-09-2012 | 12-05-2012 | Class II | 157,026 Bottles | 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. | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. | Terminated |
Recalled Products
