Wells Pharmacy Recalls Glutathione Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 148 vials of Glutathione 200 mg/mL Injectable 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 148 vials of Glutathione 200 mg/mL Injectable, 30 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include 07252016@46 and 08112016@19.
The recall was initiated due to a lack of assurance of sterility. The U.S. Food and Drug Administration 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.
Consumers and healthcare providers who have purchased or possess this product should stop using it and contact Wells Pharmacy Network LLC for further instructions or a refund.
The recalled product
- Product
- Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 148
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: 07252016@46
- 08112016@19.
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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