FDA Drugs (New Approvals & NDA)Original article
American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
RegulatoryPapaverine Hydrochloride Injection, USP 60 mg/2 mLNegative
AI Analysis
Summary
American Regent, Inc. issued a voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection due to the presence of visible particulate matter (glass) identified in single dose vials.
Outcome Details
Voluntary nationwide recall of one lot due to presence of visible particulate matter identified as glass
Importance:4/10
Sentiment:
-0.80
recallproduct_safetymanufacturing_issuepapaverineinjectable
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Published by FDA Drugs (New Approvals & NDA) on August 17, 2026 2:40 PM