Agency classClass IIOur severity:High FDA (Drugs)·D-0213-2023·Announced 2023-02-01

Injectable drug product recalled due to sterility assurance failure

Pharmacy Innovations is recalling injectable glycerin/lidocaine/epinephrine products nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with theoretical sterility hazard and no reported illnesses or injuries. The facility inspection findings establish a risk-of-harm condition without actual harm reported, warranting a High severity rating per the rubric.

Plain-English summary

Pharmacy Innovations, located in Erie, Pennsylvania, is recalling injectable glycerin/lidocaine/epinephrine products (available in two formulations) distributed nationwide. The recall is due to lack of assurance of sterility.

During an FDA inspection, the agency identified insanitary conditions at the manufacturing facility. These conditions raised concerns that the injectable products may not meet required sterility standards necessary for safe use.

Healthcare providers and patients should discontinue use of affected products. If you believe you have received affected medication, contact your healthcare provider or pharmacy for guidance. Affected lot codes are t20221116@36 and t20221117@11.

The recalled product

Product: 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.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable
Hazard: sterility-failure
contamination-risk

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)

t20221116@36 t20221117@11

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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.

See all 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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