FDAClass IIAugust 7, 2024

Progesterone Injection recall: Particulate Matter

Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC…

Why was Progesterone Injection recalled?

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: CPR230029A

Product
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC…
Recalling firm
Eugia US LLC
Quantity
17136 vials
Distribution
Nationwide in the USA
Recall date
August 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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