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 12/20162) 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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