FDAClass IIRecall started August 17, 2023

EPINEPHrine 2 mg Recall: Sterility Concern

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd…

What is the FDA recall status?

The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.

How FDA enforcement data reports status

Why was EPINEPHrine 2 mg recalled?

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

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

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

Which lot codes, UPCs or models are affected?

Lot# 36-260049, Exp 10/3/2023. ;

Agency record number
D-1129-2023
Product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
340 bags
Distribution
Nationwide in the USA
Recall started
August 17, 2023
Report date
September 6, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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