Progesterone Injection Recalled Nationwide for Glass Particulate Matter
Eugia US LLC is recalling Progesterone Injection due to a market complaint of glass particles found in vials. The affected batch poses a potential risk to patients who receive injections from contaminated vials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall affecting an injectable medication contaminated with glass particulate matter. The recall meets the rubric criterion for risk-of-harm products where injury has not yet been reported, resulting in a High severity score.
Plain-English summary
Eugia US LLC is recalling Progesterone Injection USP at 500 mg per 10 mL (50 mg/mL) supplied in 10 mL multiple-dose vials. The recalled batch is 1PR24010 with expiration date 02/28/2027, comprising 17,300 vials distributed nationwide throughout the United States.
The recall was initiated following a market complaint of glass particulate matter found in a vial. Glass particles in an injectable medication pose a potential safety hazard to patients.
This recall affects all inventory from batch 1PR24010.
The recalled product
- Product
- PROGESTERONE (PROGESTERONE)
- Brand
- PROGESTERONE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable
- Hazard
- glass-particles
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 1PR24010
- Expiry: 02/28/2027
Distribution
Distributed nationwide across the United States.
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