Drug Enforcement D-0762-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 31, 2023

Termination Date

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Product Information

Product description
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Product quantity
2,249,980 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
Sagent Pharmaceuticals Inc
Address
1901 N Roselle Rd Ste 450, N/A

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

Codes & Dates

Recall number
D-0762-2023
Event ID
92376
Recall initiation date
May 19, 2023
Center classification date
May 23, 2023
Code info
Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
More code info
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