Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 122 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.
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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Wells Pharmacy Network LLC is recalling 122 syringes of Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe. The recall was initiated due to 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 the product prepared between 02/22/2016 and 09/14/2016, within their expiry dates. Known lot codes include 04142016@107 and 05242016@128.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 122
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 (3)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 04142016@107
- 05242016@128
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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