FDA Drug Class II — Moderate

AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML NASO-NEB 60 ML (10 DIFFERENT PRODUCTS)

Hazard

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.

Products

AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPH
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #'s: 0404547, 0404385, 0410167, 0410170, 0410171, 0404102, 0404102, 0404547, 0380221, 0373088, 0398747, 0390360, 0402572

Units Affected

15 units