Wells Pharmacy Recalls Testosterone Propionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 469 vials of compounded Testosterone Propionate 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 source text identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly given the risk of serious adverse health consequences associated with non-sterile injectable drugs.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 469 vials of Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04042016@2, 04282016@1, 05262016@2, 06272016@8, and 08162016@12.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer could not guarantee that the injectable medication was free from microbial contamination. The U.S. Food and Drug Administration has classified this recall as Class II, indicating 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 dispensed this product should stop using it immediately. Patients should contact their healthcare provider for alternative treatment options. The recalling firm, Wells Pharmacy Network LLC, is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable Steroids
- Affected units
- 469
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 code: 04042016@2
- 04282016@1
- 05262016@2
- 06272016@8
- 08162016@12.
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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