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American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
Date:3/15/2011

>onceningthe useofthe productoreasonsforthisecallshouldconactheProfessionalServicesDeparmentat1-877-788-3232.Anyadvese reactions experiencedwiththe use of this poduct should be reported toAmericanRegent,Inc.viaemailatPV@luitpold.com, byfax o(610)650-7781or (610)650-0170oryhoneat1-800-734-9236.  TOEXPEDITEHANDLINGPLEASEDONOT REPO ANYTHINGOTHETHANSPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX O PHONE.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm

  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178

  • Bacteriostatic Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).


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    SOURCE Luitpold Pharmaceuticals, Inc.
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