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Carolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pa

DrugsSource: FDA (drug) · Date: 2026-10-14

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Carolina Infusion, LLC
Product
TIRZEPATIDE/CYANOCOBALAMIN 64/2 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 / hazard
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-09-10
Code info
Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026.
Product quantity
29.6 mls - in patient specific syringe dose
Voluntary mandated
Voluntary: Firm initiated
City
Ridgeland
State
SC
Country
United States
Event id
99867
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