Ammonium Molybdate Recall: Particles in Another American Regent Drug

American Regent has recalled another drug due to the presence of particulate matter found floating in the vials of their injectable medication. 

An ammonium molybdate injection recall was announced yesterday by the FDA and American Regent after particles were found in some lots of the medication. Only one lot was released to the public and is being recalled. The drug is manufactured by Luitpold Pharmaceuticals, Inc. and distributed by American Regent.

Ammonium molybdate is a supplement for total parenteral nutrition (TPN) solutions; which are given to patients having gastrointestinal problems to maintain their nutrition level. Ammonium molybdate is used to prevent the depletion of endogenous stores in the body.

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American Regent did not identify the particles found in ammonium molybdate vials in the recall announcement, however, the company warned that injection of the particles could cause disruption of blood flow to the small vessels in the lungs, localized inflammation and granuloma formation.

The recall affects one lot of Ammonium Molybdate Injections, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vials with an NDC of 0517-6610-25. Only lot # 9409 is affected by the recall. The vials have an expiration date of June 2011.

This is the fifth drug distributed by American Regent to be recalled due to particulate matter contamination in less than a year. The company recalled seven lots of Dexamethasone in late December, 2010, and then expanded that recall to include vials of sodium bicarbonate. In January, there was an acetadote recall, followed by a sodium thiosulfate recall in February and a sodium chloride recall in March.

American Regent is crediting the accounts of all customers who return the recalled vials. Any patients or health care providers with questions can call 1-877-788-3232.


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