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, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Reported: July 26, 2017 Initiated: July 6, 2017 #D-0980-2017
Product Description
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, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Details
- Recalling Firm
- Hospira Inc., A Pfizer Company
- Units Affected
- 701 vials
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01. Recalled by Hospira Inc., A Pfizer Company. Units affected: 701 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2017. Severity: Low. Recall number: D-0980-2017.
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