D-0436-2016 Class II Terminated
FDA drug recall D-0436-2016 was initiated by Western Drug on Oct 19, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Oct 1, 2016). Affected quantity: 4 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 9, 2015
- Initiation Date
- Oct 19, 2015
- Termination Date
- Oct 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 containers
Product Description
Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Code Information
all lots
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0436-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026