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. NDC: 0409-1140-01
Reported: September 19, 2018 Initiated: August 28, 2018 #D-1184-2018
Product Description
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. NDC: 0409-1140-01
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 1,580 vials
- Distribution
- Nationwide USA
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. NDC: 0409-1140-01. Recalled by Pfizer Inc.. Units affected: 1,580 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Low. Recall number: D-1184-2018.
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