Cytotec recall: Impurity Out of Spec
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
Why was Cytotec recalled?
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
- 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
- Recalling firm
- Pfizer Inc.
- Quantity
- 1,706 cartons
- Distribution
- Nationwide
- Recall date
- January 18, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)