Drug 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
Lots and codes
1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 1,706 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 9, 2016
- Terminated
- August 18, 2017
Related products
- Cytotec – drug information
- NDC 0025-1461 Cytotec · Misoprostol 200 ug/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0025-1451 Cytotec · Misoprostol 100 ug/1 · Pfizer Laboratories Div Pfizer Inc