D-0480-2017 Class II Terminated
FDA drug recall D-0480-2017 was initiated by Hospira Inc., A Pfizer Company on Feb 10, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance: customer report of leaking bag The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 578,784 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 1, 2017
- Initiation Date
- Feb 10, 2017
- Termination Date
- Apr 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 578,784 bags
Product description
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Reason for recall
Lack of Sterility Assurance: customer report of leaking bag
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot: 54-054-JT, 6/1/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0480-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026