US Compounding Recalls Phenylephrine and Lidocaine Vials Due to Sterility Concerns
US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection 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 and involves a sterile injectable product where sterility assurance is compromised, posing a significant risk of serious injury or hospitalization from infection.
Plain-English summary
US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1%, 1 mL Single Use Vials intended for intracameral injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries the NDC 62295-3155-01. The specific lot code is 20151506@31, with a beyond-use date of 9/13/2015.
The recall was initiated because of deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within their expiry date to address this lack of assurance of sterility.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Affected units
- 542
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: 20151506@31 BUD: 9/13/2015
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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