2/7/2025

Hydroxocobalamin Injection

Products Affected - Description

- Cyanokit intravenous powder for solution for injection, BTG International (Serb Pharmaceuticals), 5 gram, vial, NDC 50633-0310-11

Reason for the Shortage

- Serb Pharmaceuticals has the current batch of Cyanokit on hold while the company investigates an issue at the contract manufacturer.

Available Products

- There are no presentations available

Estimated Resupply Dates

- Serb Pharmaceuticals has Cyanokit on back order and the company estimates a release date of 2nd quarter 2025.

Safety

- FDA is allowing certain batches to be released by Serb Pharmaceuticals that have a quality defect related to sterility. Although these batches met required specifications for release, including sterility and endotoxin, SERB Pharmaceuticals is unable to assure their sterility or endotoxin content. Healthcare providers should weigh the potential benefit of using Cyanokit against the potential risk of infection. Detailed information can be found at: https://www.fda.gov/media/185400/download
- Healthcare Professionals should administer these Cyanokit batches via an IV administration set equipped with a 0.2-micron inline filter with a polyethersulfone (PES) filtration membrane and having a membrane surface greater than or equal to 10 cm2.
- Patients who receive Cyanokit should be closely monitored for signs of systemic infection or sepsis. If systemic infection or sepsis is suspected (e.g., fever, persistent hypotension indicative of shock), initiate blood cultures and start empiric antibiotic therapy, adjusting based on pathogen identification and susceptibility results.

Updated

Updated February 7, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 1, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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