US Compounding Recalls Cyclopent/PE/Tropic Eye Drops Due to Sterility Concerns
US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, an FDA Class II recall involving a sterile medical product where sterility assurance is compromised is assigned a severity score of 4 (Severe) due to the potential for significant injury or infection.
Plain-English summary
US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%) ophthalmic eye drops. The product is compounded for topical ophthalmic use and is available by prescription only. The recall covers specific lot numbers 20151806@22 and 20152306@36, with best-use dates of December 15, 2015, and December 20, 2015, respectively.
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 the sterile preparations. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled eye drops and contact their pharmacist or healthcare provider for guidance on disposal or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 820
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 (2)
- Lot Numbers: 20151806@22 BUD: 12/15/2015
- 20152306@36 BUD: 12/20/2015
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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