Exela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill

Plain-English summary

Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials. The recall was initiated on May 5, 2020, and was classified as Class III by the U.S. Food and Drug Administration. The reason for the recall is a short fill, meaning the vials may not contain the full labeled volume of the medication.

The affected product is identified by Lot #P0000471, Catalog #2020TS002, and an expiration date of 04/2021. The product was distributed nationwide and in Puerto Rico. The recall was initiated by the firm and was terminated on January 14, 2022.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or the manufacturer. No adverse health consequences are expected from this recall, as it is classified as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product

Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

Manufacturer

Exela Pharma Sciences LLC

Category

Drug — Injectable Medication

Hazard

• short-fill

Affected units

23,775

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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