FDAClass IIMay 24, 2023

Cefepime for Injection recall: Sterility Concern

Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41

Why was Cefepime for Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots within expiry.

Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
Recalling firm
Astral SteriTech Private Ltd.
Quantity
51,280 vials
Distribution
Nationwide within the United States
Recall date
May 24, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls