Wells Pharmacy Recalls Mitomycin Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Mitomycin 20 mg 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable drug.
Plain-English summary
Wells Pharmacy Network LLC is recalling 315 kits of Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vials. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product was compounded by Wells Pharmacy in Ocala, FL, and distributed nationwide. The recall includes all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known kit lot codes include 05122016@84 and 07012016@107, while known vial lot codes include 04212016@149 and 06082016@7.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description.
The recalled product
- Product
- Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 315
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 (4)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 05122016@84
- 07012016@107. Known vial lot code: 04212016@149
- 06082016@7.
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.
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