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Drug FDA Class II Ongoing Foreign material

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 55150-306-10.

Eugia US LLC Published Aug 7, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Glass · primary

Affected products (1)

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 55150-306-10.

PROGESTERONE · 17136 vials

NDC: 55150-306, 55150-306-10
Code info: Lot #: CPR230029A

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 26, 2024
  2. Published
    Aug 7, 2024
Recall number
D-0624-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.