Recalls / Class II
Class IID-1526-2022
Product
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Carolina Infusion
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 95 Bees Creek Rd, Ridgeland, South Carolina 29936-7540
Distribution
- Quantity
- 16 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-08-26
- FDA classified
- 2022-09-15
- Posted by FDA
- 2022-09-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1526-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.