New Life Pharma LLC Class II Drug Recall for Tirzepatide Inj
Summary
The FDA has initiated a Class II drug recall for New Life Pharma LLC's Tirzepatide Inj (NDC 84223-002-03) due to a lack of assurance of sterility. The recall affects product distributed in Ohio.
What changed
The Food and Drug Administration (FDA) has issued a Class II drug recall for New Life Pharma LLC's Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial (NDC 84223-002-03). The reason for the recall is a lack of assurance of sterility. The affected product was distributed in Ohio.
New Life Pharma LLC must ensure all affected product is removed from the market and that appropriate corrective actions are taken to address the sterility issue. Compliance officers should verify that their inventory does not contain the recalled product and implement procedures to prevent future occurrences of sterility failures. Failure to comply with recall procedures can result in further enforcement actions.
What to do next
- Verify inventory for recalled Tirzepatide Inj (NDC 84223-002-03)
- Implement procedures to address sterility assurance failures
Source document (simplified)
New Life Pharma LLC
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0394-2026 · 20260311 · Ongoing
Product
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Reason for Recall
Lack of Assurance of Sterility
Distribution
OH
Source: openFDA Enforcement API
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