Status
Ongoing
Drug Enforcement D-0532-2023
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.
Classification
Class III
Report Date
April 19, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 1,926 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0532-2023
- Event ID
- 91872
- Recall initiation date
- March 8, 2023
- Center classification date
- April 13, 2023
- Code info
- Lot W054586A, EXP 03/2026
- More code info
- —