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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Exela Pharma Sciences LLC: Potassium Acetate Injection Recalled Due to Short Fill Vials

Agency Publication Date: September 14, 2020
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Summary

Exela Pharma Sciences LLC is recalling 23,775 vials of Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) because some vials may be 'short filled,' meaning they contain less medication than the labeled amount. This recall affects one specific lot of single-dose vials distributed nationwide and in Puerto Rico. Because this is a prescription medication used in clinical settings, a short fill could lead to a patient receiving an incorrect dose of potassium. Consumers should check their supply for lot number P0000471 and contact their healthcare provider or pharmacist for further guidance.

Risk

A short-fill vial contains less than the intended volume of medication, which can lead to the administration of an under-dose to the patient. For potassium acetate, an under-dose may fail to properly treat or prevent potassium deficiency (hypokalemia), which is critical for heart and muscle function.

What You Should Do

  1. Check your medication supply for Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials with NDC 51754-2001-4.
  2. Locate the lot number and expiration date on the vial label to see if it matches Lot #P0000471 (Catalog #2020TS002) with an expiration date of 04/2021.
  3. If you identify an affected vial, do not use it; contact your healthcare provider or pharmacist immediately for clinical guidance and to arrange for a replacement.
  4. Return any unused product from the affected lot to your pharmacy or the place of purchase for a refund.
  5. Contact Exela Pharma Sciences LLC directly at 1245 Blowing Rock Blvd, Lenoir, North Carolina for more information regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials
Model:
NDC 51754-2001-4
Catalog #2020TS002
Recall #: D-1585-2020
Lot Numbers:
P0000471 (Exp Date: 04/2021)
Date Ranges: Expiration Date: 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86288
Status: Resolved
Manufacturer: Exela Pharma Sciences LLC
Sold By: Nationwide and Puerto Rico distributors
Manufactured In: United States
Units Affected: 23,775 vials
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.