Class II
Terminated
FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
This recall has been terminated (originally issued August 22, 2012).
- Recall Initiated
- May 25, 2012
- Posted
- August 22, 2012
- Recall Number
- D-1521-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2 units
- Firm Location
- Ocala, FL, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Lot / Code Info
Rx #: 0398930
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