FDA Drug recall D-1184-2018
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…
- FDA Drug
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of 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… by Pfizer, citing failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1184-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-28 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
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
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Identifiers
| code_info | Lot: DP602, 10/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1184-2018%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.