Cytotec Tablet
FDA Recall NDC 0025-1461
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cytotec (NDC 0025-1461). A significant event, classified as Class III, was initiated on Sep 09, 2016 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2016 Class III Recall: Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Recall Number
Class III Terminated
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Sep 09, 2016
Jan 18, 2017
1,706 cartons
Recall Profile & Regulatory Data
Event ID
75321
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 18, 2017
Product Description
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
Affected Packages Involved in this Recall
0025-1451-34Product
0025-1451-60Product
0025-1461-34Product
0025-1461-60Product
0025-1461-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
