Visible Particulates in Vials Prompt American Regent Recall

American Regent reports on FDA's Web site that the company is recalling Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial, NDC # 0517-2502-10. The recall only affects lot #0084. No other lots of Caffeine & Sodium Benzoate Injection, USP are subject to this voluntary recall, the company reports.

The vials are being recalled because some were found with visible particulates, American Regent reports. "Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. Intramuscular administration could result in foreign body inflammatory response, with local pain, swelling and possible long term granuloma formation," American Regent reports on FDA's site.

Caffeine and Sodium Benzoate Injection has been used as part of treatments for respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol).

Caffeine & Sodium Benzoate Injection, USP is manufactured by Luitpold Pharmaceuticals Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Several products have been recalled over the past year because of particulates ranging from "inert stainless steel particles" to "fungal microbial contaminants" to "glass flakes from delamination."

In 2011, the Parenteral Drug Association (PDA; and Rx-360 ( are studying some of the challenges the pharmaceutical industry has encountered with recalls associated with glass vials. Several recalls have involved the discovery of particulate matter inside the vials of injectible drugs.

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