American Regent Drug Recall: Silicon Particles in Calcium Gluconate

One lot of calcium gluconate injections distributed by American Regent has been recalled due silicone particle contamination. 

The American Regent calcium gluconate recall was announced by the FDA on July 18, after some vials were found to contain particulate matter. The particles could disrupt blood flow in the small blood vessels of the lungs, cause inflammation and granuloma formation.

The recall notice did not explain how the silicon particles contaminated the vials, but indicated that there have been no reports of injuries from contaminated calcium gloconate injections.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The recall affects lot #1006 of Calcim Gluconate Injection, USP, 10%, 100 mL. The affected vials have an expiration date of January 2013 and NDC # 0517-3900-25. No other lots are affected by the recall.

Calcium gluconate is used in the treatment black widow spider bites, as well as calcium deficiency caused by hypocalcemic tetany, hypocalcemia linked to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used to treat rickets, osteomalacia, lead colic, magnesium sulfate overdose, some side effects of allergic conditions and conditions linked to hyperkalemia.

American Regent and the FDA are warning hospitals, clinics and other healthcare facilities not to use calcium gluconate injections affected by the recall. They have been instructed to immediately quarantine any affected supplies and return them to American Regent.

American Regent has said it will credit the accounts of facilities who return the potentially contaminated vials. Anyone with questions should call American Regent’s customer service department at 1-877-788-3232. Adverse reactions should be reported to American Regent and the FDA’s MedWatch Adverse Event Reporting program at

Image Credit: |


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024
Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024 (Posted yesterday)

A federal judge is allowing plaintiffs to file large numbers of Suboxone tooth decay lawsuits in one bundled complaint, to meet a potential two-year statute of limitations deadline, with the ability to flesh those claims out in more detail at a later date.