Drug Enforcement D-1023-2013

Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

Status

Terminated

Classification

Class II

Report Date

September 18, 2013

Termination Date

January 21, 2014

Product Information

Product description
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
Product quantity
85 mL
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.
Recall initiation reason
Initial firm notification
Press Release
Distribution pattern
Nationwide

Location & Firm

Recalling firm
University Compounding Pharmacy
Address
1875 3rd Avenue, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-1023-2013
Event ID
66206
Recall initiation date
September 6, 2013
Center classification date
September 12, 2013
Code info
Lot #: 497940, Exp 9/6/2013
More code info