US Compounding Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
US Compounding Inc is recalling Phenylephrine 10% PF Ophthalmic Solution 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
US Compounding Inc is recalling 862 bottles of Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, for topical ophthalmic use. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries NDC 62295-3273-03.
The recall is being conducted 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 codes are 20151803@4, 20152005@19, 20152307@15, and 20153003@4, with corresponding best-use-by dates ranging from September 2015 to January 2016.
The product was distributed nationwide. 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
- Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic Solution
- Affected units
- 862
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 Code: 20151803@4 BUD: 9/14/2015
- 20152005@19 BUD: 11/16/2015
- 20152307@15 BUD: 1/19/2016
- 20153003@4 BUD: 9/26/2015
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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