Tirofiban Hydrochloride Injection 12.5 mg/250 mL recall
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC…
Why was Tirofiban Hydrochloride Injection 12.5 mg/250 mL recalled?
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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# : 3TF24001, Exp 3/31/2026
- Product
- Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC…
- Recalling firm
- Eugia US LLC
- Distribution
- USA nationwide.
- Recall date
- May 7, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)