Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
| Recalling firm | Carolina Infusion, LLC |
|---|---|
| Reason | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Sep 10, 2026 |
| Region | SC, United States |
| Distribution | Nationwide within the U.S |
| Quantity | 15 mLs - in patient specific syringe doses |
| Code/Lot | Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0022-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0022-2027)
openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)
Find out more
- Search this recall on FDA fda.gov ↗
- Search related news (Google News) news.google.com ↗
- Search this product (Google) google.com ↗
The links above open external searches by recall number / product name; the results are the responsibility of each site.
This page summarizes U.S. FDA data for general information and is not medical advice. Confirm details via official FDA announcements and the manufacturer.