US Compounding Recalls Voriconazole Eye Drops Due to Sterility Concerns
US Compounding Inc is recalling specific lots of Voriconazole eye drops because deficient practices may have compromised sterility assurance.
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 involves a lack of sterility assurance in a sterile ophthalmic preparation, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is recalling Voriconazole Solution (1% (10 mg/mL), 15 mL dropper bottle) for topical ophthalmic use. The recall affects two dropper bottles from Lot Code 20150209@40, which had a beyond-use date of September 16, 2015. The product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have impacted the sterility assurance of all sterile preparations within their expiry dates. This is an FDA Class II recall.
Consumers who have this specific lot of Voriconazole eye drops should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 2
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)
- Lot Code: 20150209@40 BUD: 9/16/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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