Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Summary
The FDA issued a Class II for Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Ma by Amneal Pharmaceuticals of New York, LLC. Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity..
Details
Source
Drug Recall
External ID
D-0319-2024
Action Date
2024-02-14
Status
Terminated
Category
drug
Product Description
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
Lot/Code Info: Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Quantity Affected: 858 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-15
Company
Brookhaven, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals of New York, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals of New York, LLC have FDA actions?
Amneal Pharmaceuticals of New York, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0319-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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