Semaglutide Injection Recalled Due to Sterility Assurance Deficiency
The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.
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 involving a sterility assurance defect for an injectable pharmaceutical. No illnesses, injuries, or hospitalizations are reported in the source. Per the severity rubric, this qualifies as High—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vital Care Compounder (Pharmacy Plus, Inc.) is recalling semaglutide injection 5mg/mL (0.25mg/0.05mL solution) in unit dose vials. The reason for the recall is lack of assurance of sterility.
According to the FDA, an inspection found that the products were produced in a manner that cannot guarantee sterility. The affected product is labeled and purported to be sterile, but the manufacturing process does not provide adequate assurance of this critical characteristic.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. Specific lot numbers and beyond-use dates are identified in the FDA recall notice, including lots 65680, 66043, 66372, and 66597 with beyond-use dates in October 2022.
Institutions and patients who have received the recalled semaglutide should refer to the FDA recall notice for complete lot number information and contact information for the recalling firm, Vital Care Compounder.
The recalled product
- Product
- SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug
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 (8)
- Lots: 65680
- BUD: 10/11/2022
- 66043
- BUD: 10/15/2022
- 66372
- BUD: 10/23/2022
- 66597
- BUD: 10/29/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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