Status
Ongoing
Drug Enforcement D-0763-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
May 31, 2023
Termination Date
—
Product Information
- Product description
- Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
- Product quantity
- 2,249,980 vials
- 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-0763-2023
- Event ID
- 92376
- Recall initiation date
- May 19, 2023
- Center classification date
- May 23, 2023
- Code info
- Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
- More code info
- —