Recall Impacts Exela and Civica Brands
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
Exela Pharma Sciences is recalling several products because of the presence of silicone found in retained samples. Injection with the presence of particulates such as silicone can cause irritation and swelling. If it reaches 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.
The products recalled include:
- 8.4% Sodium Bicarbonate injection, 50 ml single dose vial. This is used to treat metabolic acidosis, which is the build up of acid in the body due to kidney disease. Nine lots are being recalled and include both Exela and Civcia products with expiration dates between November 2023 and December 2024. The products were distributed between Jan. 18, 2022, and Feb. 15, 2023. For lot numbers, see FDA announcement here.
- Midazolam in 0.8% Sodium Chloride injection, 100 ml single dose vial. This is used for sedation and is packaged as 25 vials per corrugated shipper. The vials are labeled with Exela brand. One lot (10001088) has been recalled with an expiration date of July 2024. It was distributed between July 14, 2023, and Sept. 26, 2023.
- ELCYS (cysteine hydrochloride) injection, 10 ml single dose vial. It is used to meet nutritional requirements for newborns, as well as for children and adults with severe liver disease. It is packaged as 10 vials in a carton and labeled as the Exela brand. One lot (10000798) with an expiration date of March 2025.
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