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.
What this means for you
Illness, injury, or structural failure has been reported. 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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