Class III
Terminated
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
- Company
- Hospira Inc., A Pfizer Company
- Recall Initiated
- July 6, 2017
- Posted
- July 26, 2017
- Recall Number
- D-0980-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 701 vials
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Distribution
Nationwide
Lot / Code Info
Lot: DP601, exp 10/2018
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