Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Product description
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
Lot numbers, UPCs & expiration codes
Lot W054586A, EXP 03/2026
Where it was sold
Nationwide in the USA
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-0532-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Mar 8, 2023
- FDA report date
- Apr 19, 2023
- Quantity
- 1,926 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0532-2023, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 91872
- Address
- 235 East 42nd Street
- Code information
- Lot W054586A, EXP 03/2026
- Postal code
- 10017-5703
- Report date
- Apr 19, 2023
- Product type
- Drugs
- Recall number
- D-0532-2023
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1,926 Bottles
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 8, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2023