FDAClass IISeptember 18, 2013

PGE-1, 100 mcg/mL Injection in Normal Saline recall: Sterility Concern

PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.

Why was PGE-1, 100 mcg/mL Injection in Normal Saline recalled?

Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

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?

Lot #: 497930, 11/5/2013

Product
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
Recalling firm
University Compounding Pharmacy
Quantity
37.805 mL
Distribution
Nationwide
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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