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

Recall Number: D-0424-2017

Firm: Pfizer Inc.

Classification: Class III

Status: Terminated

Report Date: 20170118

Initiation Date: 20160909

Termination Date: 20170818

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

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