CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable vial recalled
Carolina Infusion is recalling MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable vial, distributed nationwide in the US. The recall was initiated on 26 Aug 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1517-2022
- FDA event ID
- 90798
- Recalling firm
- Carolina Infusion, Ridgeland, SC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 26 Aug 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Aug 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +20 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: 05042022@4 BUD: 10/31/2022; 062920222@9 BUD: 12/26/2022; 07262022@3 BUD: 01/22/2023
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
19 other products · FDA event 90798More recalls from Carolina Infusion
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Quad-mix 30MG/3MG/60MCG/0.2 Injectable vial recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tri-mix 30/2/20 Injectable vial recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | L-Carnitine 500 mg/mL Injectable vial recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable syringe recalled | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | Tri-mix 30/1/20 Injectable vial recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
Other Mic recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MIC/B12 25/50/50/1 MG/ML Injectable vial recalled by Carolina Infusion | Carolina Infusion | Sterility | Nationwide |
| Drug | CLASS II | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Mic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable vial recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | MIC/Bcomp+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 recalled | Wells Pharmacy Network | Sterility | Nationwide |