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U.S. Department of Health and Human Services

Drugs

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FDA announces Rx Formulation’s voluntary recall of sterile drug products

FDA confirms contamination in Rx Formulations’ calcium gluconate 10% product

 
[2/6/2014] FDA advises health care 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, as a precaution.
 
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, which can cause infection in patients.
 
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.
 
FDA has not received any adverse event reports associated with calcium gluconate injection from Rx Formulations. Health care professionals and consumers may report adverse events experienced with products made by Rx Formulations to the FDA’s MedWatch Adverse Event Reporting program:
 
 
FDA issued a statement on Dec. 13, 2013, advising the public about Rx Formulations’ recall of calcium gluconate 10% product, along with five other products.
 
FDA - Form 483

 

[12/13/2013] The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that 2 to 3 millimeter, irregularly shaped floating matter was observed in calcium gluconate injection from an intact, unused vial produced at Rx Formulations, Mesa, Ariz. Rx Formulations informed FDA that it is recalling products marketed as sterile that were made in the same area of the facility as the contaminated product.

The following products, compounded in Hood #2 between Nov. 7 and Dec. 11, 2013, are subject to the recall by Rx Formulations:

  • Calcium Gluconate 10%

  • Magnesium Sulfate

  • Potassium Phosphates 4.4 mEq/ml

  • Oxytocin 10 Units/ml

  • Sodium Bicarbonate 8.4%

  • Bupivacaine 3%

A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection. Therefore, these products should not be administered to patients. Health care providers and hospital staff should immediately check their medical supplies, quarantine the products being recalled, and follow the recall instructions from Rx Formulations.

Patients who were administered any sterile product produced by Rx Formulations and who have concerns should contact their health care provider.

FDA has not received any adverse event reports associated with calcium gluconate injection from Rx Formulations. FDA asks health care providers and consumers to report adverse reactions or quality problems experienced with products made by Rx Formulations to the FDA’s MedWatch Adverse Event Reporting program: