Recalls / Class II
Class IID-1527-2022
Product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Affected lot / code info
- Lots: 06272022@6 BUD: 08/26/2022; 07212022@3 BUD: 09/19/2022; 07292022@11 BUD: 09/27/2022; 08052022@7 BUD: 10/04/2022; 08102022@5 BUD: 10/09/2022; 08122022@14 BUD: 10/11/2022; 08172022@7 BUD: 10/16/2022
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
- 7 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-1527-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.