← FDA ENFORCEMENT
D-0327-2024Class II

Amneal Pharmaceuticals of New York, LLC

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Terminated
Report date
2024-02-28
Distribution
Nationwide in the USA
Firm state
NY
Product quantity
46,037 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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

Code / lot info

Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.