Exela Pharma Sciences LLC: Drug Recall

Recall #D-0116-2024 · 10/18/2023

Class I: Dangerous

Recall Details

Recall Number
D-0116-2024
Classification
Class I
Product Type
Drug
Recalling Firm
Exela Pharma Sciences LLC
Status
Ongoing
Date Initiated
10/18/2023
Location
Lenoir, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
355,220 vials

Reason for Recall

Presence of Particulate Matter: Silicone

Product Description

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

Distribution Pattern

Nationwide

Other Recalls by Exela Pharma Sciences LLC

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.