Wells Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials 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 Alprostadil 20 mcg/mL Injectable, 5 mL and 10 mL vials, due to a lack of assurance of sterility. The recalled product was compounded by Wells Pharmacy Network LLC in Ocala, Florida.
The recall includes 24 five-milliliter vials and 91 ten-milliliter vials. The affected lot codes are 03312016@6, 04222016@8, 15202016@85, 06302016@4, and 08012016@32. These products were prepared between February 22, 2016, and September 14, 2016, and are within their expiry dates. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
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. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8
- 15202016@85
- 06302016@4
- 08012016@32
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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