Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: IOPAMIDOL 41% INJECTABLE 198 ML
Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: IOPAMIDOL 41% INJECTABLE 198 ML is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab; Product: IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODI
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
|---|---|
| Product | IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS) |
| Reason for recall | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies |
| Recall initiated | 20120521 |
| Recall number | D-1549-2012 |
| Category | drug |
| State | FL |
| Country | United States |
$29/mo
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