Why it was recalled
Lack of Assurance of Sterility
Product description
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Lot numbers, UPCs & expiration codes
Lots: 07052022@8, BUD: 09/03/2022; 07292022@10, BUD: 09/27/2022
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-1528-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Aug 26, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 2 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Carolina Infusion
Original FDA data
Every field from FDA enforcement report D-1528-2022, 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: 07052022@8, BUD: 09/03/2022; 07292022@10, BUD: 09/27/2022
- Postal code
- 29936-7540
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1528-2022
- Classification
- Class II
- Recalling firm
- Carolina Infusion
- Product quantity
- 2 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TRI-MIX 30/1/40 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
- Center classification date
- Sep 15, 2022