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Showing 5801–5820 of 15081 results

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Senna Syrup (Geritrex) – Odor and Taste Issue (2019)

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Class IIModerate

FDAMay 6, 2019Nationwide• Geritrex, LLC

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Master Blend Omega (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Essential Woman Softgels (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Full Spectrum Hemp Extract (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Flax Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Omega Man Softgels (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Cod Liver Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Ideal CBD Hemp Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Olive Leaf Complex (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Ultra EPA Fish Oil (Barlean's) – Undeclared sulfites (2019)

Undeclared Allergen

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Class IIILow

FDAMay 6, 2019Nationwide• Barlean's Llc

Bevacizumab (Avella) – Sterility Concern (2019)

Lack of assurance of sterility

Class IIModerate

FDAMay 3, 2019Nationwide• Avella of Deer Valley, Inc. Store 38

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 25mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

CVS Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

DrKids Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

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