Class II · Moderate risk
Tirzepatide/Cyanocobalamin 85/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Tirzepatide/Cyanocobalamin 76/2 Mg/Ml Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Drug: Cyanocobalamin
- Recalling firm
- Carolina Infusion, LLC
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0029-2027 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Cyanocobalamin recalls
See all
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 64/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 26/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Semaglutide/Cyanocobalamin 9/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Semaglutide/Cyanocobalamin 3/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Other recalls by Carolina Infusion, LLC
All 2026 recalls
Class II · Moderate risk
Tri-MIX (Papav/Phento/Alpros)
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tri-MIX (Papav/Phento/Alpros)
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 85/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 64/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
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