US Compounding Recalls Phenylephrine PF Sterile Solution Due to Sterility Concerns
US Compounding Inc is recalling Phenylephrine PF Sterile Solution (2.5%) because deficient practices may have impacted 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 and involves a lack of sterility assurance in a sterile ophthalmic product, which poses a risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 3,860 dropper bottles of Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper. The product is compounded for topical ophthalmic use and is available by prescription only. The recall covers specific lot codes with expiration dates ranging from October 2015 to December 2015.
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 affected products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall is classified as FDA Class II.
The recalled product
- Product
- Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 3,860
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 (5)
- Lot Code: 20150206@3 BUD: 11/29/2015
- 20150306@51 BUD: 11/30/2015
- 20151106@28 BUD: 12/8/2015
- 20151404@4 BUD: 10/11/2015
- 20151606@3 BUD: 12/13/2015
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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