Exela Pharma Sciences LLC

FDA Regulatory Profile

Summary

Total Recalls
12 (7 Class I)
510(k) Clearances
0
Inspections
11
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0620-2025Class II4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL SiJuly 30, 2025
D-0303-2025Class II8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per caMarch 7, 2025
D-0117-2024Class IMidazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 counOctober 18, 2023
D-0116-2024Class I8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial October 18, 2023
D-0118-2024Class IELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile October 18, 2023
D-0079-2023Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in November 28, 2022
D-0080-2023Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in November 28, 2022
D-0023-2023Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in October 4, 2022
D-0022-2023Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in October 4, 2022
D-0369-2022Class II8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured aJanuary 11, 2022
D-1585-2020Class IIIPotassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured BMay 5, 2020
D-0826-2018Class IIDiclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, MaApril 20, 2018