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GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/E...

FDA Recall #D-0213-2023 — Class II — December 22, 2022

Recall #D-0213-2023 Date: December 22, 2022 Classification: Class II Status: Terminated

Product Description

GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for Recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Recalling Firm

Pharmacy Innovations — Erie, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide in the USA

Code Information

t20221116@36 t20221117@11

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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