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

FDA recall notice · announced January 18, 2017 · Pfizer

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Quantity: 1,706 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0424-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.