Home / Recalls / Ranbaxy Inc. / D-1288-2015

D-1288-2015 Class II Terminated

Recalled by Ranbaxy Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
August 12, 2015
Initiation Date
June 26, 2015
Termination Date
April 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,229 Boxes

Product Description

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

Reason for Recall

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

Distribution Pattern

Nationwide

Code Information

Lot #:14H04AA, Expiry: 02/28/2017.

Other recalls by Ranbaxy Inc.

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  • 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-072-2013 Class II — Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets pe (November 9, 2012)
  • D-070-2013 Class II — Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufacture (November 9, 2012)
  • D-071-2013 Class II — Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufacture (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)