Recalls / Class III
Class IIID-0424-2017
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
- Brand name
- Cytotec
- Generic name
- Misoprostol
- Active ingredient
- Misoprostol
- Route
- Oral
- NDCs
- 0025-1451, 0025-1461
- FDA application
- NDA019268
- Affected lot / code info
- 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Why it was recalled
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 1,706 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-09
- FDA classified
- 2017-01-06
- Posted by FDA
- 2017-01-18
- Terminated
- 2017-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0424-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.