Why it was recalled
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
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
Lot numbers, UPCs & expiration codes
1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0424-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 9, 2016
- FDA report date
- Jan 18, 2017
- Quantity
- 1,706 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0424-2017, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 75321
- Address
- 235 East 42nd Street
- Code information
- 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018
- Postal code
- 10017-5703
- Report date
- Jan 18, 2017
- Product type
- Drugs
- Recall number
- D-0424-2017
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1,706 cartons
- Termination date
- Aug 18, 2017
- Reason for recall
- Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 9, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2017