Recalls / Class II
Class IID-1024-2013
Product
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
- Affected lot / code info
- Lot #: 497930, 11/5/2013
Why it was recalled
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recalling firm
- Firm
- University Compounding Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1875 3rd Avenue, N/A, San Diego, California 92101
Distribution
- Quantity
- 37.805 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-06
- FDA classified
- 2013-09-12
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1024-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.