Home / Recalls / Taro Pharmaceuticals, Inc. / D-0117-2017

D-0117-2017 Class II Terminated

Recalled by Taro Pharmaceuticals, Inc. — Brampton

Recall Details

Product Type
Drugs
Report Date
November 9, 2016
Initiation Date
September 13, 2016
Termination Date
June 15, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,756 units

Product Description

Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7

Reason for Recall

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Distribution Pattern

US & Puerto Rico

Code Information

Lot #: E0598-19624, E5099-19624, Exp. Jan 2017

Other recalls by Taro Pharmaceuticals, Inc.

  • D-0089-2024 Class III — Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX (November 6, 2023)
  • D-0116-2017 Class II — Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc (September 13, 2016)
  • D-1370-2015 Class III — Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: (August 5, 2015)