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.
Reported: December 5, 2012 Initiated: November 9, 2012 #D-072-2013
Product Description
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.
Details
- Recalling Firm
- Ranbaxy Inc.
- Units Affected
- 157,026 Bottles
- Distribution
- Nationwide and PR
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ranbaxy Inc.. Units affected: 157,026 Bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-072-2013.
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