Product: 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
Reason for recall: Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Recall initiated: 20160909
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated