Recall

All recalls7,877 total

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

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Johnson, S C and Son, Inc — babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 8100359213

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

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FGF, LLC — item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201886 FLAVOREDSOUR CREAM CAKE DONUT 72x3OZ, NET WT 12.15 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.16 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201807 BAVARIAN FILLED DONUT 78x2.75OZ, NET WT 12.07 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201919 BAR YST DONUT UNFLD PFD 74x3OZ, NET WT 12.49 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201846 GEN CHOC HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201844 GEN GLD PERSIAN DONUT DGH FRZ 132x2.5OZ, NET WT 18.56 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201906 JUST BAKED CAKE STICKS 116x2.9 OZ, NET WT 21.03 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201927 APPLE FRITTER DONUT PFD 70 X 3.5OZ, NET WT 13.78 LB

potential for contamination with listeria monocytogenes

F
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FGF, LLC — item 8201842 GEN BAR DONUT DGH FRZ 132x2OZ, NET WT 14.85 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201848 GEN HEX RG DONUT DGH FRZ 96x2.75OZ, NET WT 14.86 LB

potential for contamination with listeria monocytogenes

F
FGF, LLC — item 8201836 GEN YST RING DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201865 JUST BAKED APPLE FRITTERS 72x3OZ, NET WT 13.50 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201780 GEN CHOC CK DONUT RINGS PFD 90x2.5OZ, NET WT12.66LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201900 APPLE FRITTER DONUT ZGT PFD 54x3OZ, NET WT 9.11 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201843 GEN BISMARK DONUT DGH FRZ 144x2OZ, NET WT 16.20 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201812 FRENCH CRULLERS 72x 1.6 OZ, NET WT 6.48 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201835 JUST BAKED YEAST MUNCHKINS 350x0.39 OZ, NET WT 8.49 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201817 APPLE FILLED PACZKI 66x4 OZ, NET WT 14.85 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201839 PBX YST RING DONUT PFD 108x2.12OZ, NET WT 12.88 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201921 FRENCH CRULLER PFD 72x1.6 OZ, NET WT 6.48 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201845 GEN RG HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201806 RASPBERRY FILLED DONUT 78x2.75OZ, NET WT 12.07 LB

potential for contamination with listeria monocytogenes

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FGF, LLC — item 8201870 GEN BAR FLUFF DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB

potential for contamination with listeria monocytogenes

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