March 2017 FDA Recall Nystatin And Triamcinolone Acetonide by Taro Pharmaceuticals U.s.a., Inc. (D-0676-2017 - Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability)
This Class II drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on March 28, 2017 for the product Nystatin And Triamcinolone Acetonide. The FDA reported the reason for recall as failed content uniformity specifications; out-of-specification (oos) results 18-month stability. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0676-2017
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
03-28-2017
04-26-2017
278,304 tubes
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 U.S.A., 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.
Nationwide and Puerto Rico
06-17-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Batch or Lot Expiration Information
Lot# a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
