Reported Jan 11, 2017 · Terminated
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Wells Pharmacy Network LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wells Pharmacy Network LLC · 1210 SW 33rd Ave · Ocala, FL · 34474-2853
Is this the product you have?
- Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit 2 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 3 lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94. - Amount recalled
- 2,336 kits (number of vials per kit vary by prescription)
This recall covers 97 products
The agency filed one notice per product. You are reading one of them; the other 96 are below.
84 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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