FDA Drug recall D-0980-2017
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad,…
- FDA Drug
- Class III
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class III recall of Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad,… by Hospira A Pfizer, citing failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0980-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-07-06 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira A Pfizer |
| Distribution | US |
Product
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
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Identifiers
| code_info | Lot: DP601, exp 10/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0980-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.