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Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.
|
Product |
Strength |
Vial Size |
|
8.4% Sodium Bicarbonate |
50 mEq/50 mL |
50 mL Single Dose Vial |
|
Midazolam in 0.8% Sodium |
100 mg/100 mL |
100 mL Single Dose Vial |
|
ELCYS (cysteine hydrochloride |
500 mg/10 mL |
10 mL Single Dose Vial |
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. Exela has not received any reports of adverse events related to this recall.
Date of last update: October 25, 2023
