August 2016 FDA Recall Zenatane by Dr. Reddy's Laboratories, Inc.
D-0098-2017 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on August 29, 2016 for the product Zenatane. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0098-2017
Failed Dissolution Specifications
08-29-2016
10-19-2016
3,858 prescription packs (115,680 capsules)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Dr. Reddy's Laboratories, 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
11-08-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Batch or Lot Expiration Information
Lot# 79KB60205; Exp. 02/18
