D-0532-2023 Class III Ongoing
FDA drug recall D-0532-2023 was initiated by Pfizer Inc. on March 8, 2023 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 1,926 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 19, 2023
- Initiation Date
- March 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,926 Bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot W054586A, EXP 03/2026