Agency classClass IIOur severity:High FDA (Drugs)·D-0203-2023·Announced 2023-02-01

Edetate Calcium Disodium Injectable Recalled for Sterility Assurance Concerns

Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise 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 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 no reported illnesses or injuries. The hazard (lack of sterility assurance in an injectable drug) presents significant risk of harm through potential contamination, meeting the criterion of "risk-of-harm products where injury has not yet been reported."

Plain-English summary

Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML (30ML vial) injectable vials that were distributed nationwide. The recall is due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the manufacturing facility located at 2936 W 17th St., Erie, PA.

When manufacturing conditions are insanitary, there is risk that an injectable product may become contaminated. The FDA issued this recall because the manufacturing conditions do not provide assurance that the product is free from contamination.

Patients who have received this medication should consult their healthcare provider or pharmacist. The affected product can be identified by code t20221013@15. Do not use affected units.

The recalled product

Product: Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable
Hazard: lack-of-sterility
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)

t20221013@15

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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Same hazard · lack of sterility