The Recall Desk
HighFDA (Drugs)·D-1520-2022·Announced 2022-09-21

Carolina Infusion Semaglutide/Cyanocobalamin Injectable Recalled for Sterility Issue

Carolina Infusion is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringes nationwide due to lack of sterility assurance. The affected lot 08152022@14 has a best-by date of September 14, 2022.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of an injectable medication with theoretical sterility risk and no reported illnesses or injuries. Qualifies as a risk-of-harm product without reported injury per the rubric.

Plain-English summary

Carolina Infusion LLC is recalling Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 mL syringe product because the manufacturer cannot assure that the product meets required sterility standards for injectable medications.

The affected product was distributed nationwide in the United States. The recalled lot is 08152022@14 with a best-by date of September 14, 2022.

Patients who have received this injectable should verify their lot number. Those in possession of product from lot 08152022@14 should not use it and should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer
Carolina Infusion
Category
Drug — Injectable / Combination
Hazard
  • contamination
  • sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 08152022@14 BUD: 09/14/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category