Recalls / Class II

Class IID-0380-2017

Product

Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

Affected lot / code info

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.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Wells Pharmacy Network LLC

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1210 SW 33rd Ave, N/A, Ocala, Florida 34474-2853

Distribution

Quantity

2,336 kits (number of vials per kit vary by prescription)

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-09-21

FDA classified

2017-01-04

Posted by FDA

2017-01-11

Terminated

2021-07-02

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.