US Compounding Recalls Tropicamide and Phenylephrine Eye Drops for Sterility Concerns
US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact 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 involves a sterile medical product where deficient practices may impact sterility assurance, posing a risk of serious injury or death from infection, which aligns with the 'Severe' criteria for significant injury risks in sterile preparations.
Plain-English summary
US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5%, 2 mL Dropper Bottle for Topical Ophthalmic Use. The product is prescription-only and was compounded by US Compounding Pharmacy in Conway, Arkansas. The recall is distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry date. The specific lot code is 20151606@11 with a beyond-use date of 12/13/2015.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The FDA has classified this recall as Class II.
The recalled product
- Product
- Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 1,833
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: 20151606@11 BUD: 12/13/2015
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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