Argatroban Injection recall: Impurity Out of Spec
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA.…
Why was Argatroban Injection recalled?
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 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: DP602, 10/2018
- Product
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA.…
- Recalling firm
- Pfizer Inc.
- Quantity
- 1,580 vials
- Distribution
- Nationwide USA
- Recall date
- September 19, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)