CLASS III Drug recall · Reported 23 Sep 2020 · FDA Enforcement Report
Potassium Acetate Injection, USP 40 mEq recalled
Exela Pharma Sciences is recalling Potassium Acetate Injection, USP 40 mEq/ (2 mEq/mL) Single Dose Vials, distributed nationwide in the US. The recall was initiated on 5 May 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1585-2020
- FDA event ID
- 86288
- Recalling firm
- Exela Pharma Sciences, Lenoir, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 May 2020
- FDA classified
- 14 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 5 May 2020 | Recall initiated by company | |
| 14 Sep 2020 | Classified by FDA | +132 days |
| 23 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short Fill
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Potassium Acetate Injection, USP 40 mEq/ (2 mEq/mL) Single Dose Vials recalled?
Yes. Exela Pharma Sciences recalled Potassium Acetate Injection, USP 40 mEq/ (2 mEq/mL) Single Dose Vials on 5 May 2020. The recall is Class III and its status is Terminated. Recall number D-1585-2020.
Why was it recalled?
Short Fill
Which lots are affected?
Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Exela Pharma Sciences
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | Midazolam in 8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys | Exela Pharma Sciences | Particulate Matter | Nationwide |
Other Potassium recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Potassium Acetate Injection, 2 mEq/mL recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 15 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |