Multi-event September 2016 FDA Recall Desoximetasone by Taro Pharmaceuticals, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Taro Pharmaceuticals, Inc. on September 13, 2016 for the product Desoximetasone. The FDA reported the reason for recall as failed stability specifications. The product was distributed in US & Puerto Rico and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0116-2017
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
09-13-2016
11-09-2016
15,576 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US & Puerto Rico
06-15-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desoximetasone Cream USP, 0.25% 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 51672-1270-7
Batch or Lot Expiration Information
Lot# : B5093-18608, B5094-18608, Exp. Jan 2017
Lot# : C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Affected Packages Involved in this Recall
Recall Number: D-0117-2017
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
09-13-2016
11-09-2016
6,756 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US & Puerto Rico
06-15-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : E0598-19624, E5099-19624, Exp. Jan 2017
