Class III
Terminated
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
This recall has been terminated (originally issued January 18, 2017).
- Company
- Pfizer Inc.
- Recall Initiated
- September 9, 2016
- Posted
- January 18, 2017
- Recall Number
- D-0424-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,706 cartons
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Distribution
Nationwide
Lot / Code Info
1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
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