TRI-MIX 30/2/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/2/20 Injectable due to lack of assurance of sterility. Multiple lots were distributed nationwide to healthcare providers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a lack of sterility assurance, which poses a risk of serious infection or systemic harm. However, no illnesses or injuries have been reported.
Plain-English summary
Carolina Infusion LLC is recalling TRI-MIX 30/2/20 Injectable, 10 mL vials (Rx only), due to a lack of assurance of sterility. The product was distributed nationwide.
Affected lot numbers and Beyond Use Dates are: 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), and 082620222@1 (BUD 10/25/2022).
Healthcare providers and patients should not use affected vials and should return them to Carolina Infusion LLC at 95 Bees Creek Road, Ridgeland, SC 29936.
The recalled product
- Product
- TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Hazard
- sterility-assurance-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: 07052022@10
- BUD: 09/03/2022
- 07052022@16
- 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
- 08122022@9
- BUD: 10/11/2022
- 08162022@2
- BUD: 10/15/2022
- 082620222@1
- BUD: 10/25/2022
Distribution
Distributed nationwide across the United States.
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