The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

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Same hazard · sterility

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