New Life Pharma LLC Class II Drug Recall - Semaglutide Inj
Summary
The FDA has issued a Class II drug recall for Semaglutide Inj manufactured by New Life Pharma LLC due to a lack of assurance of sterility. The recall affects product distributed in Ohio.
What changed
The Food and Drug Administration (FDA) has initiated a Class II drug recall for Semaglutide Inj (NDC 84223-001-07) manufactured by New Life Pharma LLC. The recall is due to a lack of assurance of sterility and impacts product distributed in Ohio.
This recall signifies a critical product quality issue that requires immediate attention from any entities involved in the distribution or handling of this specific Semaglutide Inj product. While the document does not specify a compliance deadline, the nature of a sterility issue necessitates prompt action to remove the product from circulation to prevent potential patient harm. Companies should review their inventory and distribution records for affected lots and coordinate with New Life Pharma and the FDA regarding disposition and reporting.
What to do next
- Review inventory and distribution records for affected Semaglutide Inj lots.
- Cease distribution of recalled product.
- Coordinate with New Life Pharma and the FDA on product disposition and reporting.
Source document (simplified)
New Life Pharma LLC
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0392-2026 · 20260311 · Ongoing
Product
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Reason for Recall
Lack of Assurance of Sterility
Distribution
OH
Source: openFDA Enforcement API
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