Drug Enforcement D-0426-2024

Failed dissolution specifications

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

August 16, 2024

Product Information

Product description
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Product quantity
21,452/100 count bottles
Reason for recall
Failed dissolution specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide.

Location & Firm

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Address
50 Horseblock Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0426-2024
Event ID
93976
Recall initiation date
December 26, 2023
Center classification date
March 27, 2024
Code info
Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
More code info
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