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Class II: temporary or reversible health riskOngoing

Sagent Pharmaceuticals Nafcillin for Injection Recall

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd

Sagent Pharmaceuticals Inc · Schaumburg, IL

Risk level
Class II
Reported by FDA
May 31, 2023
Recall ID
D-0762-2023
Check your lot numberHow we source this data

Summary

Sagent Pharmaceuticals recalled Nafcillin for Injection starting May 19, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0762-2023 on May 31, 2023. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product description

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

Lot numbers, UPCs & expiration codes

Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 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-0762-2023
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-0762-2023, 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
Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
Postal code
60195-3194
Report date
May 31, 2023
Product type
Drugs
Recall number
D-0762-2023
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, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Distribution pattern
Nationwide USA
Recall initiation date
May 19, 2023
Initial firm notification
Letter
Center classification date
May 23, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0762-2023, published May 31, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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