Why it was recalled
Lack of Assurance of Sterility
Product description
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Lot numbers, UPCs & expiration codes
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;
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0763-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 19, 2023
- FDA report date
- May 31, 2023
- Quantity
- 2,249,980 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0763-2023, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 92376
- Address
- 1901 N Roselle Rd Ste 450
- Code information
- 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;
- Postal code
- 60195-3194
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0763-2023
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 2,249,980 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
- Distribution pattern
- Nationwide USA
- Recall initiation date
- May 19, 2023
- Initial firm notification
- Letter
- Center classification date
- May 23, 2023