US Compounding Recalls Vancomycin Ophthalmic Preparations Due to Sterility Concerns
US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF 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 in this case, a critical sterility failure in a sterile preparation, align with a Severe rating (Score 4).
Plain-English summary
US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF 0.5 mL (10 mg/mL). The product is compounded 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. The specific lot code is 20152306@13, with a beyond-use date of 12/20/2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The recalling firm is US Compounding Inc, located in Conway, Arkansas.
The recalled product
- Product
- Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 494
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 Code: 20152306@13 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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