"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"...
DOSAGE AND ADMINISTRATION
The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Bacteriostatic Water for Injection, USP is supplied in a multiple-dose 30 mL plastic fliptop vial (List No. 3977).
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Hospira, Inc., Lake Forest, IL 60045 USA. FDA rev date: 6/15/2000
Last reviewed on RxList: 1/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Bacteriostatic Saline Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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