Drug Enforcement D-0327-2024

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Status

Terminated

Classification

Class II

Report Date

February 28, 2024

Termination Date

February 14, 2025

Product Information

Product description
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Product quantity
46,037 Bottles
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

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-0327-2024
Event ID
93959
Recall initiation date
February 13, 2024
Center classification date
February 16, 2024
Code info
Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
More code info
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