Exela Pharma Sciences recalls
FDA enforcement reports naming Exela Pharma Sciences LLC as the recalling firm.
- Recall reports
- 12
- Class I (serious)
- 7
- Most recent report
- Sep 17, 2025
- Sep 17, 20254.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use O…Drug · Exela Pharma Sciences LLCFailed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.Class II
- Apr 2, 20258.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose…Drug · Exela Pharma Sciences LLCLack of Assurance of SterilityClass II
- Nov 29, 2023Midazolam in 0Drug · Exela Pharma Sciences LLCPresence of Particulate Matter: SiliconeClass I
- Nov 29, 2023ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single…Drug · Exela Pharma Sciences LLCPresence of Particulate Matter: SiliconeClass I
- Nov 29, 20238.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose…Drug · Exela Pharma Sciences LLCPresence of Particulate Matter: SiliconeClass I
- Dec 21, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,…Drug · Exela Pharma Sciences LLCDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.Class I
- Dec 21, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,…Drug · Exela Pharma Sciences LLCDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.Class I
- Nov 2, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,…Drug · Exela Pharma Sciences LLCDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administrationClass I
- Nov 2, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,…Drug · Exela Pharma Sciences LLCDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administrationClass I
- Jan 19, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, M…Drug · Exela Pharma Sciences LLCLack of Assurance of SterilityClass II
- Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, M…
- Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0
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