Wells Pharmacy Recalls Testosterone Enanthate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 1,250 vials of compounded Testosterone Enanthate 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Wells Pharmacy Network LLC is recalling 1,250 vials of Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.
The recall was initiated because of a lack of assurance of sterility. The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 03282016@3, 04132016@1, 05262016@3, 06242016@97, and 07282016@1.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the medication.
The recalled product
- Product
- Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,250
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 (6)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot codes: 03282016@3
- 04132016@1
- 05262016@3
- 06242016@97
- 07282016@1
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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