PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reported: November 12, 2014 Initiated: October 6, 2014 #D-0213-2015
Product Description
PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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.
Details
- Recalling Firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Units Affected
- 46.7 mL
- Distribution
- Oregon, Washington
- Location
- Wilsonville, OR
Frequently Asked Questions
What product was recalled? ▼
PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Recalled by Oregon Compounding Centers, Inc. dba Creative Compounds. Units affected: 46.7 mL.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0213-2015.
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