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American Regent recalls injection drug due to presence of foreign matter

Filed February 27th, 2012 Joshua Sophy

American Regent has issued a recall on an prescription injection drug because vials in a specific Lot of the drug may contain particulate matter.

Injection drug vials which contain foreign substances, anything from dust to microscopic pieces of chipped glass, could lead to life-threatening complications for patients being treated with the drug.

In its recall, American Regent said Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials included with Lot 0693 must be recalled because they contain particulate matter. The company does not indicate in its press release announcing the recall if any injuries or incidents have resulted from a foreign substance found in one of these vials.

Particulate matter in a vial of this or any drug could result in disruption of blood flow, especially in the smaller vessels in the lungs, or inflammation or granular formations. Larger pieces of foreign matter in an injected drug could cause considerably more damage, including damage to blood vessels.

According to the release, Phenylephrine HCl Injection is used to maintain “adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension or hypersensitivity. The injection is also approved for use in several other indications.

The injection drug was available at the hospital and retail pharmacy level. All hospitals and pharmacists are being urged to isolate and quarantine any vials included in the affected Lot. This Lot was distributed nationwide to wholesalers and drug distributors.

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