Succinylcholine Injection recalled for lack of sterility assurance
Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility failure in an injectable pharmaceutical. The source does not report any illnesses, injuries, or hospitalizations. Sterility failure in injectables constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for score 3.
Plain-English summary
Apollo Care, LLC is recalling Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), in single-use syringes, due to lack of assurance of sterility.
The affected product is Lot #AC-016607 with an expiration date of 05/09/2023. This lot was distributed in Missouri only.
Succinylcholine is a neuromuscular blocking agent used in anesthesia and critical care. Injectable medications must be sterile to prevent serious infections. Patients or healthcare facilities that may have received this product should contact Apollo Care, LLC or their healthcare provider immediately. Affected syringes should not be used.
The recalled product
- Product
- Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable / Anesthetic
- Hazard
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AC-016607
- Exp. Date 05/09/2023
Distribution
Distribution scope not specified by the agency.
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