Reported Feb 14, 2024 · Terminated

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals…

Amneal Pharmaceuticals of New York, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Is this the product you have?

  • Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only
  • Manufactured byAmneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India
  • Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
Lot codes and dates
    • Lot # AM221153
    • Exp. date 06/30/2024
    • AM230497
    • Exp. date 02/29/2025
Amount recalled
858 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 31, 2025 · Data as of Sep 19, 2:53 PM UTC

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