D-0885-2018 Class II Terminated
FDA drug recall D-0885-2018 was initiated by ICU Medical Inc on May 31, 2018 and is designated Class II. Reason for recall: Lack of assurance of sterility: Bags have potential to leak. The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 267288 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 27, 2018
- Initiation Date
- May 31, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 267288 bags
Product Description
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Reason for Recall
Lack of assurance of sterility: Bags have potential to leak.
Distribution Pattern
Nationwide and Canada
Code Information
Lot #: 86-033-JT, Exp 08/01/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0885-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026