Agency classClass IIOur severity:Severe FDA (Drugs)·D-0380-2017·Announced 2017-01-11

Wells Pharmacy Recalls Mitomycin Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 2,336 Mitomycin 40 mg Injectable kits nationwide due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility is not assured is categorized as Severe (Score 4) due to the potential for serious adverse health consequences.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 2,336 kits of Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vials. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. Specific lot codes for both kits and vials are listed in the official recall documentation.

The recalled product

Product: Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 2,336

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (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
07072016@94.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 97 recalled by Wells Pharmacy Network LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 97 products in this recall →

Same manufacturer · Wells Pharmacy Network LLC

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