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

Recall date

September 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0424-2017

FDA classification

Class III

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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