Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: EPINEPHRINE **(25X1ML AMPULS) 1
Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: EPINEPHRINE **(25X1ML AMPULS) 1 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: EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
|---|---|
| Product | EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS SULFITES) 1:1000 (1MG/ML) INJECTABLE 15 ML, 16 ML, 30 ML (15 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 because 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, and West Indies |
| Recall initiated | 20120525 |
| Recall number | D-1514-2012 |
| Category | drug |
| State | FL |
| Country | United States |
$29/mo
Try RecallGuard →