Compounded Semaglutide Injection Recalled Due to Sterility Assurance Failure
Vital Care Compounder is recalling C-Semaglutide 5mg/mL injection in 0.5mL vials due to lack of assurance of sterility. The recall affects 45 vials distributed in Mississippi.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of a compounded injectable medication with a manufacturing defect (lack of sterility assurance). While the hazard poses potential risk to patients, no illness or hospitalization has been reported in the source text, placing this at High severity.
Plain-English summary
Vital Care Compounder is recalling C-Semaglutide 5mg/mL injection in 0.5mL vials due to a manufacturing defect: lack of assurance of sterility. The FDA classified this as a Class II recall.
The affected product is Lot #73810 with expiration date May 1, 2023. A total of 45 vials were distributed in Mississippi. This is a prescription-only (Rx) medication.
Patients or healthcare providers who have obtained this product should contact Vital Care Compounder or consult with a healthcare professional regarding the recall.
The recalled product
- Product
- C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable / Compounded
- Hazard
- Affected units
- 45
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 #: 73810
- Exp. Date 5/1/2023
Distribution
Distributed in 1 state:
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