Why it was recalled
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Product description
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
Lot numbers, UPCs & expiration codes
Lot #: 2407258, Exp 05/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-060-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2012
- FDA report date
- Nov 28, 2012
- Quantity
- 32,208 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ranbaxy Inc.
Original FDA data
Every field from FDA enforcement report D-060-2013, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63623
- Address
- 600 College Rd E Ste 2100
- Code information
- Lot #: 2407258, Exp 05/14
- Postal code
- 08540-6636
- Report date
- Nov 28, 2012
- Product type
- Drugs
- Recall number
- D-060-2013
- Classification
- Class II
- Recalling firm
- Ranbaxy Inc.
- Product quantity
- 32,208 bottles
- Termination date
- Mar 6, 2014
- Reason for recall
- Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2012