Wells Pharmacy Recalls Indocyanine Green Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 131 kits of Indocyanine Green (P.F.) 15 mg Injectable 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 infection or serious injury.
Plain-English summary
Wells Pharmacy Network LLC is recalling 131 kits of Indocyanine Green (P.F.), 15 mg Injectable Kit. 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 affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include kit lot 08232016@42 and vial lot 08172016@45. The number of vials per kit varies by prescription.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on returns or replacements.
The recalled product
- Product
- Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 131
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 (1)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
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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