TOPIC: Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags by Central Admixture Pharmacy Services (CAPS): Recall - Due to Visible Black Particulate Matter in a Single-Sealed Vial
AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy
ISSUE: Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride.
To date, CAPS has not received any reports of adverse events or injuries associated with this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death.
RECOMMENDATIONS:
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Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Patients with questions regarding this recall can contact CAPS by calling 1-844-903-6417.
- CAPS is notifying its distributors and customers by USPS certified mail and is arranging for return. By completing a “Urgent Pharmaceutical Recall Response Form” and either faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in the customer’s possession is zero (0).
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