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Showing 101–120 of 123 results

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Happy Tot Oat Bar Bananas (Happy Family) – Mold Growth (2020)

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Class IIModerate

FDAOct 12, 2020AL, AZ, AR +36 more• Nurture Inc. dba Happy Family

Happy Tot Oat Bar Blueberries (Happy Family) – Mold Growth (2020)

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Class IIModerate

FDAOct 12, 2020AL, AZ, AR +36 more• Nurture Inc. dba Happy Family

Panagel Hand Sanitizer (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Alcohol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Ethanol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Modesa Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

NuuxSan Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Assured Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Next Advanced Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Valsartan 40mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Valsartan 320mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Dryses Deodorant Men (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

Repaskin 30 Sunscreen (Sesderma) – Manufacturing Quality Issue (2015)

cGMP Deviations; product does not comply with cGMP requirements

Class IIModerate

FDAOct 15, 2015CO, FL, GA +1 more• Sesderma, SL

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