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Cal-GLU FDA Alerts

The FDA Alert(s) below may be specifically about Cal-GLU or relate to a group or class of drugs which include Cal-GLU (calcium gluconate).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for calcium gluconate

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

Oct 21, 2017

Audience: Pharmacy, Health Professional

ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination.  See the recall notice for a full list of products.

BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.

RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[10/20/2017 - Recall Notice - SCA Pharmaceuticals]

Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination

Feb 7, 2014

Audience: Health Professional, Risk Manager, Patient

ISSUE: FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations’ calcium gluconate injection product. The testing identified gram-positive rod bacteria in the product. A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection.

BACKGROUND: Rx Formulations recalled products marketed as sterile on December 13, 2013.

RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, and quarantine the affected products.

Patients who were administered any drug marketed as sterile produced by Rx Formulations between Nov. 7 and Dec. 11, 2013, and who have concerns, should contact their health care provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/06/2014 - FDA Drug Safety Statement - FDA]
 

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Aug 10, 2013

Audience: Pharmacy, Patient, Health Professional

[Update 08/11/2013] FDA News Release is now available. 

[Update 08/10/2013] Specialty Compounding, LLC has announced a voluntary nationwide recall of all lots of unexpired sterile products. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time.

Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina.

Refer to the Firm Press Release for additional details. 

 

[Posted 08/09/2013]

ISSUE: Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections.

 

BACKGROUND: Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

RECOMMENDATION: FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/11/2013] - News Release - FDA]

[08/10/2013 - Firm Press Release - Specialty Compounding]

[08/09/2013 - Alert - FDA]

 

 

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Aug 9, 2013

Audience: Pharmacy, Patient, Health Professional

 

[Posted 08/09/2013]

ISSUE: Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections.

BACKGROUND: Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

RECOMMENDATION: FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/09/2013 - Alert - FDA]

American Regent Injectable Products: Recall - Visible Particulates in Products

Jul 20, 2011

Audience: Pharmacy

  • Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006)
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials (Lot #0362)
  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP

 

[UPDATED 07/20/2011] Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006) recalled.

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled. See Press Release for lot information.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled. See Press Release for lot information.

[Posted 02/05/2011]

ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[07/18/2011 - Press Release, Calcium Gluconate Injection, American Regent]
[06/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent]
[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

More Cal-GLU Resources