FDAFDA · Food and drugs·Recall number D-0380-2017
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Published January 11, 2017 · Recall initiated: September 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Wells Pharmacy Network LLC
- Distributor
- Nationwide
- Lot
- All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@201, 04202016@33, 05182016@46, 05232016@227, 06072016@55, 06092016@88, 06142016@60, 07012016@112, 07132016@142, 07292016@121, 07292016@129. Known vial lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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