The Recall Desk
HighFDA (Drugs)·D-0538-2023·Announced 2023-04-26

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.

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 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
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 #: 73810
  • Exp. Date 5/1/2023

Distribution

Distributed in 1 state:

  • MS