Fagron Compounding Services recalled 5,140 bags of norepinephrine Bitartrate injection due to lack of sterility assurance. A blue Break-Off-Part could detach from the administration port. The recall covers nationwide distribution in the U.S. Consumers should stop use and contact providers for guidance.
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter
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Norepinephrine Bitartrate injections are used as vasopressors in critical care to raise blood pressure in hypotensive patients. They are typically prepared in hospital pharmacies or compounding centers.
A blue Break-Off-Part could detach from the administration port, raising sterility concerns and potential contamination risk.
This recall is not part of a broader industry pattern beyond sterility assurance issues in compounded IV solutions.
Immediate discontinuation is required for affected bags. Hospitals and patients may experience delays in critical vasopressor therapy while replacements are sourced.
Recall details are on FDA enforcement page and packaging labels.
Refunds/replacements typically managed through hospital purchasing channels; no public timeline specified.
Document lot numbers, expiration dates, and correspondences with the manufacturer and FDA.
Product: Norepinephrine Bitartrate, 32 mg per 250 mL 0.9% Sodium Chloride Injection USP. Company: Fagron Compounding Services. Address: 8710 34th St. N. Wichita, KS 67226. NDC: 71266-5027-02. Lot numbers and expirations include: C274-000050004 Exp. 4/24/2026; C274-000050295 Exp. 5/8/2026; C274-000050773 Exp. 6/4/2026; C274-000051219 Exp. 6/21/2026; C274-000051318 Exp. 6/27/2026; C274-000051602 Exp. 7/12/2026. Quantity: 5140 bags. Distribution: Nationwide in the USA. Recall date: 2026-03-20.
No injuries or incidents have been reported.
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