← FDA ENFORCEMENT
D-0426-2024Class II

Amneal Pharmaceuticals of New York, LLC

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Terminated
Report date
2024-04-03
Distribution
Product was distributed nationwide.
Firm state
NY
Product quantity
21,452/100 count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed dissolution specifications

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

Code / lot 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

Other recalls SPEQ maps to Validation & Qualification
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.