MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma ...
FDA Recall #D-0532-2023 — Class III — March 8, 2023
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
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.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,926 Bottles
Distribution
Nationwide in the USA
Code Information
Lot W054586A, EXP 03/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated