Argatroban Injection — Class III drug recall D-1184-2018
Terminated recall by Pfizer Inc., reported 2018-09-19, distributed nationwide. Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month t
| Recall number | D-1184-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2018-09-07 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,580 vials |
| Reason classes | specification failure |
| NDC | 00409-1140-01 |
| Lot numbers | DP602 |
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 for recall
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1184-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.