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American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates
Date:7/18/2011

was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Calcium Gluconate Injection, USP, 10%, Lot # 1006 for patient care, and should immediately quarantine any product for return to American Regent, Inc.

Please Note: Calcium Gluconate Injection, USP, 10% is a supersaturated solution and is prone to precipitation. Other lots and sizes may contain a precipitate that should dissolve upon warming. The Product Package Insert contains directions on dissolving this precipitate should it occur. However, the injection must be clear at the time of use. As stated in the Package Insert: "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."  

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.

Hospitals, infusion centers, clinics and other healthcare facilities, with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232: Monday thru Friday from 9:00 AM to 5:00 PM EDT.  

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at pv@luitpold.com, by fax to (610) 650-0170 or by phone at 1-800-734-9236: Monday thru Friday from 9:00 AM to 5:00 PM EDT.  TO EXPEDITE HANDLING, PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS
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SOURCE Luitpold Pharmaceuticals, Inc.
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