Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 41 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe.
Plain-English summary
Wells Pharmacy Network LLC is recalling 41 syringes of Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe. The product was compounded by Wells Pharmacy in Ocala, Florida. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. One known lot code is 05022016@160.
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.
The product was distributed nationwide. 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 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 41
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 (2)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 05022016@160
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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