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D-0380-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0380-2017 was initiated by Wells Pharmacy Network LLC on Sep 21, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jul 2, 2021). Affected quantity: 2,336 kits (number of vials per kit vary by prescription).

Recall Details

Product Type: Drugs
Report Date: Jan 11, 2017
Initiation Date: Sep 21, 2016
Termination Date: Jul 2, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,336 kits (number of vials per kit vary by prescription)

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

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.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0380-2017
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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D-0341-2017 Class II — Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials… (Sep 21, 2016)
D-0415-2017 Class II — Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials… (Sep 21, 2016)
D-0355-2017 Class II — DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle… (Sep 21, 2016)