FDA Drug recall D-1585-2020
Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, N…
- FDA Drug
- Class III
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class III recall of Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, N… by Exela Pharma Sciences, citing short Fill.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1585-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-05 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Exela Pharma Sciences |
| Distribution | US |
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
Reason
Short Fill
Identifiers
| code_info | Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Exela Pharma Sciences
- 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured a…
FDA Drug · Class II · 2025-09-17 · Exela Pharma Sciences - 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only…
FDA Drug · Class II · 2025-04-02 · Exela Pharma Sciences - 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences - ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, R…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences - Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences
All Exela Pharma Sciences recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1585-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.