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Class II: temporary or reversible health riskCompleted

Carolina Infusion TRI-MIX 30/1/10 Injectable Recall

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek R…

Carolina Infusion · Ridgeland, SC

Risk level
Class II
Reported by FDA
Sep 21, 2022
Recall ID
D-1526-2022
Check your lot numberHow we source this data

Summary

Carolina Infusion recalled TRI-MIX 30/1/10 Injectable starting Aug 26, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1526-2022 on Sep 21, 2022. Reason: Lack of Assurance of Sterility. Status: Completed.

Why it was recalled

Lack of Assurance of Sterility

Product description

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Lot numbers, UPCs & expiration codes

Lots: 06282022@1, BUD: 08/27/2022; 06292022@8, BUD: 08/28/2022; 07012022@19, BUD: 08/30/2022; 07012022@3, BUD: 08/30/2022; 07122022@8, BUD: 09/10/2022; 07132022@9, BUD: 09/11/2022; 07192022@1, BUD: 09/17/2022; 07292022@9, BUD: 09/27/2022; 08032022@10, BUD: 10/02/2022; 08092022@2, BUD: 10/08/2022; 08102022@1, 08102022@6, 08102022@7, BUD: 10/09/2022; 08152022@5, BUD: 10/14/2022; 08192022@1, 08192022@10, BUD: 10/18/2022

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1526-2022
Classification
Class II
Status
Completed
Recall initiated
Aug 26, 2022
FDA report date
Sep 21, 2022
Quantity
16 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Carolina Infusion

Original FDA data

Every field from FDA enforcement report D-1526-2022, exactly as published.

Show all FDA fields
City
Ridgeland
State
SC
Status
Completed
Country
United States
Event ID
90798
Address
95 Bees Creek Rd
Code information
Lots: 06282022@1, BUD: 08/27/2022; 06292022@8, BUD: 08/28/2022; 07012022@19, BUD: 08/30/2022; 07012022@3, BUD: 08/30/2022; 07122022@8, BUD: 09/10/2022; 07132022@9, BUD: 09/11/2022; 07192022@1, BUD: 09/17/2022; 07292022@9, BUD: 09/27/2022; 08032022@10, BUD: 10/02/2022; 08092022@2, BUD: 10/08/2022; 08102022@1, 08102022@6, 08102022@7, BUD: 10/09/2022; 08152022@5, BUD: 10/14/2022; 08192022@1, 08192022@10, BUD: 10/18/2022
Postal code
29936-7540
Report date
Sep 21, 2022
Product type
Drugs
Recall number
D-1526-2022
Classification
Class II
Recalling firm
Carolina Infusion
Product quantity
16 vials
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Aug 26, 2022
Initial firm notification
E-Mail
Center classification date
Sep 15, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1526-2022, published Sep 21, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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