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Recall Observatory FDA recall evidence

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

September 09, 2016

Class III

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

    reason.potency_specification_failure · v1.0.0

    Out of specification