D-1023-2013 Class II Terminated
FDA drug recall D-1023-2013 was initiated by University Compounding Pharmacy on September 6, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. The recall status is terminated (terminated January 21, 2014). Affected quantity: 85 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2013
- Initiation Date
- September 6, 2013
- Termination Date
- January 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 mL
Product Description
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
Reason for Recall
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Distribution Pattern
Nationwide
Code Information
Lot #: 497940, Exp 9/6/2013