FDA recall D-0424-2017

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-09-09

Report date

2017-01-18

Termination date

2017-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2017