FDAFDA · Food and drugs·Recall number D-0424-2017
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
Published January 18, 2017 · Recall initiated: September 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYTOTEC
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- UPC
- 0300251461606
- Lot
- 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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