Argatroban Injection recall: Impurity Out of Spec
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India…
Why was Argatroban Injection recalled?
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
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: DP601, exp 10/2018
- Product
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India…
- Recalling firm
- Hospira Inc., A Pfizer Company
- Quantity
- 701 vials
- Distribution
- Nationwide
- Recall date
- July 26, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)