Home / Recalls / Ranbaxy Inc. / D-060-2013

D-060-2013 Class II Terminated

Recalled by Ranbaxy Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
November 28, 2012
Initiation Date
August 21, 2012
Termination Date
March 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,208 bottles

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

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.

Distribution Pattern

Nationwide

Code Information

Lot #: 2407258, Exp 05/14

Other recalls by Ranbaxy Inc.

  • D-1288-2015 Class II — Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/ (June 26, 2015)
  • D-1086-2014 Class II — Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manuf (January 16, 2014)
  • D-162-2013 Class III — Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, R (December 27, 2012)
  • D-163-2013 Class III — Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes) (December 27, 2012)
  • D-071-2013 Class II — Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufacture (November 9, 2012)
  • D-070-2013 Class II — Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufacture (November 9, 2012)
  • D-072-2013 Class II — Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets pe (November 9, 2012)
  • D-1405-2012 Class III — Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7% (March 16, 2012)