"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(trypan blue) Ophthalmic Solution
VisionBlue® (trypan blue ophthalmic solution) 0.06% is a sterile solution of trypan blue (an acid di-azo group dye). VisionBlue® (trypan blue) is a selective tissue staining agent for use as a medical aid in ophthalmic surgery.
Each mL of VisionBlue® 0.06% contains: 0.6 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na2HPO4.2H2O); 0.3 mg sodium di-hydrogen orthophosphate (NaH2PO4•2H2O); 8.2 mg sodium chloride (NaCl); and water for injection. The pH is 7.3 - 7.6. The osmolality is 257-314 mOsm/kg.
The drug substance trypan blue has the chemical name 3,3'-[(3,3'-dimethyl-4,4'-biphenylylene) bis (azo)] bis(5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C34H24N6Na4O14S4, and has the following chemical structure:
Last reviewed on RxList: 4/8/2009
This monograph has been modified to include the generic and brand name in many instances.
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