The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1585-2020·Announced 2020-09-23

Exela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill

Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP due to short fill issues.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

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
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.

Lot numbers (3)

  • Lot #P0000471
  • Catalog #2020TS002
  • Exp Date: 04/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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