Recalls / Class III
Class IIID-0532-2023
Product
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
- Brand name
- Mektovi
- Generic name
- Binimetinib
- Active ingredient
- Binimetinib
- Route
- Oral
- NDC
- 70255-010
- FDA application
- NDA210498
- Affected lot / code info
- Lot W054586A, EXP 03/2026
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Array BioPharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 1,926 Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-08
- FDA classified
- 2023-04-13
- Posted by FDA
- 2023-04-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0532-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.