Home / Recalls / Ranbaxy Inc. / D-163-2013

D-163-2013 Class III Terminated

Recalled by Ranbaxy Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
February 20, 2013
Initiation Date
December 27, 2012
Termination Date
April 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,535 tubes and bottles

Product Description

Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.

Reason for Recall

Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13

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-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-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)