FDA Drug recall D-0380-2017
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
- FDA Drug
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL by Wells Pharmacy Network, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0380-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-21 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wells Pharmacy Network |
| Distribution | US |
Product
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@20…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Wells Pharmacy Network
- Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL
FDA Drug · Class II · 2017-01-11 · Wells Pharmacy Network - Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
FDA Drug · Class II · 2017-01-11 · Wells Pharmacy Network - Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
FDA Drug · Class II · 2017-01-11 · Wells Pharmacy Network - TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
FDA Drug · Class II · 2017-01-11 · Wells Pharmacy Network - Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL
FDA Drug · Class II · 2017-01-11 · Wells Pharmacy Network
All Wells Pharmacy Network recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0380-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.