Exela Pharma Sciences Potassium Acetate Injection Recall

Why it was recalled

Short Fill

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1585-2020
Classification: Class III
Status: Terminated
Recall initiated: May 5, 2020
FDA report date: Sep 23, 2020
Quantity: 23,775 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Exela Pharma Sciences LLC

Original FDA data

Every field from FDA enforcement report D-1585-2020, exactly as published.

Show all FDA fields

City: Lenoir
State: NC
Status: Terminated
Country: United States
Event ID: 86288
Address: 1245 Blowing Rock Blvd
Code information: Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021
Postal code: 28645-3618
Report date: Sep 23, 2020
Product type: Drugs
Recall number: D-1585-2020
Classification: Class III
Recalling firm: Exela Pharma Sciences LLC
Product quantity: 23,775 vials
Termination date: Jan 14, 2022
Reason for recall: Short Fill
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: May 5, 2020
Initial firm notification: Letter
Center classification date: Sep 14, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1585-2020, published Sep 23, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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