Agency classClass IIOur severity:Severe FDA (Drugs)·D-0245-2016·Announced 2015-11-25

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.

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, 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
Hazard: sterility
infection
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.

See all 59 products in this recall →

Same manufacturer · US Compounding Inc

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Same hazard · sterility