Drug 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
D-0424-2017
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 75321
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,706 cartons
- Official record key
drug-enforcement:D-0424-2017
Official wording
Reason: Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Code information: 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification