RecallDepth
Class II Terminated

PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

Company
Oregon Compounding Centers, Inc. Dba Creative Compounds
Recall Initiated
October 6, 2014
Posted
November 12, 2014
Recall Number
D-0213-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
46.7 mL
Firm Location
Wilsonville, OR, United States

Reason for Recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution

Oregon, Washington

Lot / Code Info

Lot #: 20140708@30, discard date: 12/2/2014

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