Recalls / Class II
Class IID-1530-2022
Product
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Affected lot / code info
- Lots: 07052022@10, BUD: 09/03/2022; 07052022@16, BUD: 09/03/2022; 07122022@11, BUD: 09/08/2022; 07182022@17, BUD: 09/16/2022; 07202022@6, BUD: 09/18/2022; 07252022@9, BUD: 09/23/2022; 0729202222@2, BUD: 09/27/2022; 07292022@13, BUD: 09/27/2022; 08122022@9, BUD: 10/11/2022; 08162022@2, BUD: 10/15/2022; 082620222@1, BUD: 10/25/2022
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
- 11 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-1530-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.