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
Reported: January 18, 2017 Initiated: September 9, 2016 #D-0424-2017
Product Description
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
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 1,706 cartons
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 1,706 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2017. Severity: Low. Recall number: D-0424-2017.
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