D-0980-2017 Class III Terminated
FDA drug recall D-0980-2017 was initiated by Hospira Inc., A Pfizer Company on Jul 6, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point The recall status is terminated (terminated Sep 10, 2019). Affected quantity: 701 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 26, 2017
- Initiation Date
- Jul 6, 2017
- Termination Date
- Sep 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 701 vials
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
Distribution pattern
Nationwide
Code information
Lot: DP601, exp 10/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0980-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026