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Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethleh...

FDA Recall #D-0612-2023 — Class II — May 15, 2023

Recall #D-0612-2023 Date: May 15, 2023 Classification: Class II Status: Terminated

Product Description

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Astral SteriTech Private Ltd. — Vadodara, N/A

Classification

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

Product Type

Drugs

Product Quantity

65,950 vials

Distribution

Nationwide within the United States

Code Information

All lots within expiry.

Status

Terminated

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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