Drug Enforcement D-0764-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 31, 2023

Termination Date

—

Product Information

Product description
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Product quantity
370,200 bottles
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
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-0764-2023
Event ID
92376
Recall initiation date
May 19, 2023
Center classification date
May 23, 2023
Code info
Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025
More code info
—