Recall -- Firm Press Release
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American Regent Initiates Voluntary Nationwide Recall of
Calcium Gluconate Injection, USP, 10%,
100 mL Pharmacy Bulk Package
Due to Particulates
877-788-3232 (Customer Service)
800-734-9236 (American Regent, Inc.)
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
FOR IMMEDIATE RELEASE - July 18, 2011 - American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:
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 email@example.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 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.
- 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.
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.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.