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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 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

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

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

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

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

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

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

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

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

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

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

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

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

Ranitidine Tablets 150mg (AuroMedics) – Empty Bottles (2019)

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

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

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

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

Dryses Antiperspirant (Sesderma) – Manufacturing Quality Issue (2015)

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

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