Mektovi Tablet, Film Coated
FDA Recall NDC 70255-010
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mektovi (NDC 70255-010). A significant event, classified as Class III, was initiated on Mar 08, 2023 by Array Biopharma Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
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.
Mar 08, 2023
Apr 19, 2023
1,926 Bottles
Recall Profile & Regulatory Data
Event ID
91872
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# Lot W054586A, EXP 03/2026
Affected Packages Involved in this Recall
70255-010-02Product
70255-010-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
