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Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: FORSKOLIN/PHENTOLAMINE 200MCG /

Franck's Lab Inc., d.b.a. Franck's Compounding Lab Recall: FORSKOLIN/PHENTOLAMINE 200MCG / is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab; Product: FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT); Reason for recall: La

Recalling firmFranck's Lab Inc., d.b.a. Franck's Compounding Lab
ProductFORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
Reason for recallLack 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Recall initiated20120525
Recall numberD-1524-2012
Categorydrug
StateFL
CountryUnited States

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