US Compounding Recalls Tropicamide and Phenylephrine Ophthalmic Drops
US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops 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 is classified as FDA Class II and involves a lack of assurance of sterility in ophthalmic preparations, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops. The product is a prescription-only compounded medication intended for topical ophthalmic use. The recall covers specific lots with expiration dates ranging from October 2015 to January 2016.
The recall was initiated due to deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry to address this lack of assurance of sterility.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 751
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 (3)
- Lot Code: 20151307@4 BUD: 1/9/2016
- 20151805@30 BUD: 11/14/2015
- 20152004@23 BUD: 10/17/2015
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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