Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 325 vials of Ultra-Test 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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product corresponds to a Severe (4) rating.
Plain-English summary
Wells Pharmacy Network LLC is recalling 325 vials of ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates. Specific known lot codes include 04152016@2, 05052016@2, 05192016@7, 07142016@28, and 09122016@23.
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
- ULTRA-TEST (CYP 80%/PROP 20%) 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
- 325
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: 04152016@2
- 05052016@2
- 05192016@7
- 07142016@28
- 09122016@23
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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