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Life sciences · Safety recall
U.S. Food and Drug Administration · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Safety recall.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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FDA enforcement report D-0029-2027. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Carolina Infusion, LLC. Initiated as: Voluntary: Firm initiated. Product: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason for recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Distribution: Nationwide within the U.S