Caffeine and Sodium Benzoate Recall Issued Due to Particulate Matter

American Regent has been forced to recall yet another drug due to possible contamination by foreign particles, known as particulate matter. This time it is caffeine and sodium benzoate injections.  

The American Regent caffeine and sodium benzoate injection recall was announced on May 5 by the FDA. The recall notice does not identify the particles and there were no reports of injuries or illnesses.

American Regent warns that injecting a patient with the contaminated drugs could cause disruption of blood flow in the small blood vessels in the lung, localized inflammation and granuloma formation.

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Caffeine and sodium benzoate injections are often used to help treat respiratory depression caused by a narcotics, pain killers or alcohol overdose. However, most experts have been voicing doubts on using caffeine as part of the overdose treatment process and recommend using other treatment methods.

The recall affects one lot of American Regent Inc., Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vials. The recalled vials have a lot number of 0084.

The recall comes about one week after an American Regent ammonium molybdate injection recall was issued for similar problems with particulate matter. This is at least the sixth such recall issued in less than a year by the drug maker.

American Regent also 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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