Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Sesame Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.
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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). Lack of sterility assurance in an injectable drug presents a significant risk of serious injury.
Plain-English summary
Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Sesame Oil Injectable, 200 mg/mL, 10 mL vials. The recall is being conducted because the product lacks assurance of sterility. The affected product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.
The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04182016@33 and 06022016@5. The product quantity involved is 3 vials.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 3
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: 04182016@33
- 06022016@5
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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