Progesterone Injection recall
FDA recall D-0624-2024 · initiated Jul 26, 2024
Eugia US LLC recalled Progesterone Injection in Jul 2024 — an FDA Class II recall (D-0624-2024) because Presence of Particulate Matter: Complaint received of a glass particle in the vial.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 17136 vials
Details
- 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 55150-306-10.
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 26, 2024
- FDA report date
- Aug 7, 2024
Frequently asked
- Was Progesterone Injection recalled?
- Eugia US LLC recalled Progesterone Injection in Jul 2024 — an FDA Class II recall (D-0624-2024) because Presence of Particulate Matter: Complaint received of a glass particle in the vial. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Progesterone Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0624-2024 was: Presence of Particulate Matter: Complaint received of a glass particle in the vial.
- Is a recalled Progesterone Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Progesterone Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: CPR230029A. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0624-2024.