Home / Recalls / Ranbaxy Inc. / D-071-2013

D-071-2013 Class II Terminated

Recalled by Ranbaxy Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
December 5, 2012
Initiation Date
November 9, 2012
Termination Date
April 28, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
203,198 Bottles

Product Description

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

Reason for Recall

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Distribution Pattern

Nationwide and PR

Code Information

Lot #s: 2436731, 2437381, 2437940, 2437942, 2437945, 2437947, 2437952, 2437953, 2437960, 2440676, 2440677, 2440680, 2440681, Exp 08/31/2014.

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-163-2013 Class III — Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes) (December 27, 2012)
  • D-162-2013 Class III — Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, R (December 27, 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-060-2013 Class II — Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manuf (August 21, 2012)
  • D-1405-2012 Class III — Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7% (March 16, 2012)