TOPIC: One Lot of Papaverine Hydrochloride Injection USP, 60 mg/2 mL by American Regent: Recall - Due to the Presence of Visible Particulate Matter
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Pulmonology, Neurology, Urology
ISSUE: American Regent is recalling a single lot of Papaverine Hydrochloride Injection USP, 60 mg/2 mL single dose vial due to the presence of particulate matter identified as glass and/or paraformaldehyde.
Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk.
To date, American Regent has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels, primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction.
This product is an intravenous injection and is to be used by or under the direction of a physician.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers and healthcare professionals with questions regarding this recall can contact American Regent. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.
- Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
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