D-0509-2019 Class II Terminated
FDA drug recall D-0509-2019 was initiated by ICU Medical Inc on February 4, 2019 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated June 4, 2020). Affected quantity: 475320 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 475320 bags
Product Description
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Reason for Recall
CGMP Deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 91-016-JT, Exp. July 01, 2020