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Class II: temporary or reversible health riskOngoing

Sagent Pharmaceuticals Oxacillin for Injection Recall

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd

Sagent Pharmaceuticals · Schaumburg, IL

Risk level
Class II
Reported by FDA
Aug 2, 2023
Recall ID
D-0935-2023
Check your lot numberHow we source this data

Summary

Sagent Pharmaceuticals recalled Oxacillin for Injection starting Jul 11, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0935-2023 on Aug 2, 2023. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product description

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

Lot numbers, UPCs & expiration codes

Lot: OXG301, Exp 12/31/2025

Where it was sold

Nationwide in the 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-0935-2023
Classification
Class II
Status
Ongoing
Recall initiated
Jul 11, 2023
FDA report date
Aug 2, 2023
Quantity
65,710 vials for 1 g and 2 g strength
Recall type
Voluntary: Firm initiated
Recalling firm
Sagent Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0935-2023, exactly as published.

Show all FDA fields
City
Schaumburg
State
IL
Status
Ongoing
Country
United States
Event ID
92678
Address
1901 N Roselle Rd Ste 450
Code information
Lot: OXG301, Exp 12/31/2025
Postal code
60195-3194
Report date
Aug 2, 2023
Product type
Drugs
Recall number
D-0935-2023
Classification
Class II
Recalling firm
Sagent Pharmaceuticals
Product quantity
65,710 vials for 1 g and 2 g strength
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jul 11, 2023
Initial firm notification
Letter
Center classification date
Jul 21, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0935-2023, published Aug 2, 2023. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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