Recalls / Class II
Class IID-1532-2022
Product
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Affected lot / code info
- Lot: 07052022@2, BUD: 09/03/2022
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
- 1 vial
- 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-1532-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.