G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
Reported: August 22, 2012 Initiated: May 25, 2012 #D-1527-2012
Product Description
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
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 because 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
- 6 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Location
- Ocala, FL
Frequently Asked Questions
What product was recalled? ▼
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS). Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Units affected: 6 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 because 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-1527-2012.
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