US Compounding Recalls Cyclo/PE/Tropic/Ketor Ophthalmic Drops for Sterility Concerns
US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for serious harm from non-sterile ophthalmic products in a Class II context aligns with the Severe criteria.
Plain-English summary
US Compounding Inc is recalling 1,198 bottles of Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%) ophthalmic drops. The product is a 10 mL dropper bottle intended for topical ophthalmic use and is available by prescription only. The recall is being conducted nationwide.
The recall is 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 dates. The affected lot numbers are 20152707@22, 20150707@9, 20152906@15, and 20152907@2, with corresponding best-use dates ranging from September 27, 2015, to October 27, 2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 1,198
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 (4)
- Lot Numbers: 20152707@22 BUD: 10/25/2015
- 20150707@9 BUD: 10/5/2015
- 20152906@15 BUD: 9/27/2015
- 20152907@2 BUD: 10/27/2015
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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