Progesterone Injection Recalled for Glass Particulate Matter in Vials
Eugia US LLC is recalling Progesterone Injection vials nationwide due to glass particles found in the product. Patients and healthcare providers should stop using the affected lot.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall with no reported hospitalizations or injuries. However, glass particulate matter in an injectable product poses a potential risk of injection-related harm, meeting the rubric criterion for Score 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Eugia US LLC is recalling Progesterone Injection, USP, 500 mg per 10 mL (50 mg/mL), in 10 mL multiple-dose vials. The recall affects lot number CPR230029A, which comprises 17,136 vials distributed nationwide in the USA.
The recall was initiated following a complaint of glass particles found in a vial. Because Progesterone Injection is administered by intramuscular injection, the presence of glass particulate matter in the product poses a potential risk of injury to patients.
Patients currently using this product from the recalled lot should contact their healthcare provider. Healthcare professionals and pharmacists should immediately discontinue dispensing the recalled product from lot CPR230029A and quarantine remaining inventory. Consumers should not use this product and should consult their healthcare provider about alternative treatments.
The recalled product
- Product
- PROGESTERONE (PROGESTERONE)
- Brand
- PROGESTERONE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 17,136
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 (1)
- Lot #: CPR230029A
Distribution
Distributed nationwide across the United States.
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