PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 25, 2015 Initiated: September 12, 2015 #D-0273-2016

Product Description

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

Reason for Recall

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Details

Recalling Firm
US Compounding Inc
Units Affected
542 vials
Distribution
Nationwide
Location
Conway, AR

Frequently Asked Questions

What product was recalled?
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. Recalled by US Compounding Inc. Units affected: 542 vials.
Why was this product recalled?
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-0273-2016.