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

FDA Recall #D-0935-2023 — Class II — July 11, 2023

Recall #D-0935-2023 Date: July 11, 2023 Classification: Class II Status: Ongoing

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.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Sagent Pharmaceuticals — Schaumburg, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

65,710 vials for 1 g and 2 g strength

Distribution

Nationwide in the USA

Code Information

Lot: OXG301, Exp 12/31/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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