September 2016 FDA Recall Cytotec by Pfizer Inc.
D-0424-2017 - Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
This Class III drug recall was voluntarily initiated by Pfizer Inc. on September 9, 2016 for the product Cytotec. The FDA reported the reason for recall as failed impurities/degradations specifications; out of specification results for two known degradation products and total impurities at 18 months. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0424-2017
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
09-09-2016
01-18-2017
1,706 cartons
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.
Pfizer 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
08-18-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Batch or Lot Expiration Information
Lot# 1)
Lot# B08493 - Expiration Date 12/2016; 2)
Lot# B13230 - Expiration Date 08/2018
