Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 146 vials of compounded Testosterone Cypionate Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
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 for significant injury or property-damage reports or high-risk contamination scenarios.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 146 vials of Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial. The recall is being conducted because of a lack of assurance of sterility in 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. Known lot codes include 04142016@5, 04292016@5, 05022016@6, and 07062016@7.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 146
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 (5)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 04142016@5
- 04292016@5
- 05022016@6
- 07062016@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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