Class I recall: American Regent, Inc.: Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-

American Regent, Inc. issued a Class I recall of Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), supplied in 2 mL single-dose vials (NDC 0517-4002-01) and 25x2 mL single-dose vial packs (NDC 0517-4002-25). The recall notice states the product was found to be contaminated with particulate matter identified as glass and/or paraformaldehyde. The FDA classifies this as a Class I recall, its most serious category, indicating use of the affected product could cause serious injury or death.

Most relevant for: Patients receiving papaverine hydrochloride injections for vasodilation or patients undergoing procedures where this medication is administered

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