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Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica In...

FDA Recall #D-0591-2023 — Class II — May 15, 2023

Recall #D-0591-2023 Date: May 15, 2023 Classification: Class II Status: Terminated

Product Description

Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10

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

419,680 vials

Distribution

Nationwide within the United States

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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