Navigation Links
American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates

SHIRLEY, N.Y., July 18, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:

Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package, Lot # 1006, Expiration Date: January 2013, NDC # 0517-3900-25

PLEASE NOTE:  This voluntary nationwide recall, initiated on July 18, 2011 to the user and consumer level is for lot # 1006 only. No other sizes or lots of Calcium Gluconate Injection, USP, are subject to this voluntary recall.    

This voluntary recall was initiated because some of the vials of this lot may contain silicone particles.  Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.   American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of product is administered to patients.  

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage.

Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, non-thrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy.

The product 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, 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 OR FAX OR 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, by regular mail, or by fax.

This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

Calcium Gluconate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
(Date:11/24/2015)... PUNE, India , November 24, 2015 ... new market research report "Spine Biologics Market by Product Type ... Type (Anterior Cervical Discectomy and Fusion, Posterior Lumbar Interbody Fusion), ... by MarketsandMarkets, the global market was valued at $1.90 Billion ... 2020, at a CAGR of 4.4% during the forecast period ...
(Date:11/24/2015)... , Nov. 24, 2015 Avery Biomedical Devices ... pleased to announce the appointment of Anders Jonzon ... Dr. Jonzon is ... at Children,s Hospital, Uppsala University, Uppsala and Children,s Hospital, ... he was a fellow at the Cardiovascular Institute (UCSF). ...
(Date:11/24/2015)... 24, 2015 . ... adds Latest Guidebook for Chinese Medical Device ... published in November 2015 to the medical devices ... library at . ... growing global economies with a fifth population in ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Cancer patients, ... and experiences at a live taping of the next CURE Connections® ... of Gastrointestinal Cancers 2015 Symposium at Georgetown University Hotel & Conference Center in ...
(Date:11/24/2015)... ... 2015 , ... With Thanksgiving right around the corner, holiday travel season is ... your family and vehicle. , According to the National Highway Traffic Safety Administration, 301 ... sharing the following safety tips from the NHTSA: , ...
(Date:11/24/2015)... ... November 24, 2015 , ... Chiropractic student Katie Benson received ... in Overland Park, Kansas. Benson, a fifth-trimester student in the university’s College of ... on October 16. , “Katie is very excited and greatly appreciative to receive ...
(Date:11/24/2015)... ... November 24, 2015 , ... Bibliomotion is thrilled to announce ... about Reinvention and Diversity by Nancy M. Schlichting, Chief Executive Officer of ... to adequately address the needs of patients and their families, shaped my desire to ...
(Date:11/24/2015)... ... ... All her life, Don Peck’s mother wondered if she was a descendant of Samuel Fuller, ... After a 25-year search for information, Don and his aunt discovered that she was not, ... Turns out, it was Don’s father who was descended from not one, but four passengers ...
Breaking Medicine News(10 mins):