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Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical...

FDA Recall #D-0584-2023 — Class II — May 15, 2023

Recall #D-0584-2023 Date: May 15, 2023 Classification: Class II Status: Terminated

Product Description

Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15

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

8,925 bottles

Distribution

Nationwide within the United States

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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