Argatroban Injection 50 mg per recall: Particulate Matter
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC…
Why was Argatroban Injection 50 mg per recalled?
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
- Product
- Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC…
- Recalling firm
- Eagle Pharmaceuticals Inc.
- Quantity
- 19,660 vials
- Distribution
- New Jersey
- Recall date
- August 8, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)