D-1184-2018 Class III Terminated
FDA drug recall D-1184-2018 was initiated by Pfizer Inc. on Aug 28, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point The recall status is terminated (terminated Jun 26, 2020). Affected quantity: 1,580 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 19, 2018
- Initiation Date
- Aug 28, 2018
- Termination Date
- Jun 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,580 vials
Product Description
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
Distribution Pattern
Nationwide USA
Code Information
Lot: DP602, 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-1184-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026