Safety Report: Exela & Civica injection products - recalled due to particulate matter presence, USA

United States

Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling several products to the consumer level because particulate matter identified as silicone was observed during routine inspection of retain samples. Exela has not received any reports of adverse events related to this recall. These products were distributed nationwide to wholesalers.

The recalled products are:
- 8.4% Sodium Bicarbonate Injection, USP. Strength: 50 mEq/50 mL. Vial Size: 50 mL Single Dose Vial. It is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01). The affected product lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
Brand Lot Expire Date
Exela P0001429 11/2023
Exela P0001900 08/2024
Exela P0001902 08/2024
Exela P0001903 09/2024
Exela P0001909 09/2024
Civica P0001912 08/2024
Exela P0001945 09/2024
Exela P0002002 11/2024
Exela P0002052 12/2024
The product was distributed nationwide to wholesalers, distributors, and health systems between January 18, 2022 and February 15, 2023.

- Midazolam in 0.8% Sodium Chloride Injection. Strength: 100 mg/100 mL. Vial Size: 100 mL Single Dose Vial. It is used for sedation and is packaged in a 100 mL glass vial, 25 vials per corrugated shipper. The vials are labeled with Exela brand (Carton NDC: 51754-2131- 4; Vial NDC: 51754-2131-1). The affected product includes the following lot number and expiration date:
Brand Lot Expire Date
Exela 10001088 07/2024
The Product was distributed nationwide to wholesalers, distributors, and health systems between July 14, 2023, and September 26, 2023.

- ELCYS (cysteine hydrochloride injection), USP. Strength: 500 mg/10 mL. Vial Size: 10 mL Single Dose Via. It is used for nutritional requirements per total parenteral nutrition (TPN) and is packaged in a 10 mL glass vial, 10 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-1007-3; Vial NDC: 51754-1007-1). The affected product includes the following lot number and expiration date:
Brand Lot Expire Date
Exela 10000798 03/2025
The product was distributed nationwide to wholesalers, distributors, health systems, and compounders between July 20, 2023, and August 1, 2023.

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.

Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela and Civica Brands
Product recalled: Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection ELCYS (cysteine hydrochloride Injection), USP
Reason of the recall: Potential presence of particulate matter
FDA Recall date: October 25, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-84-sodium-bicarbonate-injection-usp-50