PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
Reported: August 22, 2012 Initiated: May 21, 2012 #D-1591-2012
Product Description
PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
Reason for Recall
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Details
- Recalling Firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Units Affected
- 2 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Location
- Ocala, FL
Frequently Asked Questions
What product was recalled? ▼
PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT). Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Units affected: 2 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1591-2012.
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