US Compounding Recalls Cyclo/PE/Trop PF Eye Drops for Sterility Concerns
US Compounding Inc is recalling 135 bottles of Cyclo/PE/Trop PF 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 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 135 bottles of Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottles, for topical ophthalmic use. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is available by prescription only. The specific lot number is 20150707@5 with a beyond-use date of January 3, 2016.
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. The distribution of the affected product was nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 135
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 Numbers: 20150707@5 BUD: 1/3/2016
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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