Drug 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
D-0532-2023
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 91872
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,926 Bottles
- Official record key
drug-enforcement:D-0532-2023
Official wording
Reason: 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.
Code information: Lot W054586A, EXP 03/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing