Recalls / Class II
Class IID-0447-2016
Product
PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Affected lot / code info
- all lots
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Western Drug
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 105 W Main St, Springerville, Arizona 85938-7203
Distribution
- Quantity
- 9 containers
- Distribution pattern
- Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Timeline
- Recall initiated
- 2015-10-19
- FDA classified
- 2015-12-01
- Posted by FDA
- 2015-12-09
- Terminated
- 2016-10-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0447-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.