Wells Pharmacy Recalls Injectable Compounded Drug Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 22 vials of a compounded injectable drug 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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Wells Pharmacy Network LLC is recalling 22 vials of a compounded injectable drug product containing Forskolin, Papaverine, Phenylephrine, and Prostaglandin E1. The product is a 5 mL vial intended for injection.
The recall was initiated because of a lack of assurance of sterility. The affected product was prepared between February 22, 2016, and September 14, 2016, and is within its expiration date. One known lot code is 05272016@18. The product was distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to dispose of the medication safely.
The recalled product
- Product
- Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 22
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 (2)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 05272016@18.
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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