Reported Jan 18, 2017 · Terminated

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only,…

Pfizer Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703

Is this the product you have?

  • 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
Lot codes and dates
    • 1) Lot # B08493 - Expiration Date 12/2016
    • 2) Lot # B13230 - Expiration Date 08/2018
Amount recalled
1,706 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 18, 2017 · Data as of Sep 19, 6:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.