"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"...
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.
Due to the potential toxicity of benzyl alcohol in newborns, solutions containing benzyl alcohol must not be used in this patient population.
Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Bacteriostatic Saline Information
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