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Showing 1221–1240 of 3363 results

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Telmisartan Amlodipine Tablets (Lupin) – impurity specification (2019)

Failed Impurities/Degradation Specifications; 18 month long term stability study.

FDAApr 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Charms Blow Pop Watermelon Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Dubble Bubble Pink Lemonade Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Class IIILow

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Dots Orange Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Air Heads Orange Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Tootsie Roll Grape Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Tootsie Roll Vanilla Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Air Heads Strawberry Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Lemon Hand Sanitizer (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

ICEE Blue Raspberry Hand Gel (NingBo Huize) – manufacturing issues (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Dots Strawberry Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

ICEE Peach Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Dippin' Dots Cotton Candy Hand Gel (NingBo Huize) – testing deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Charms Blow Pop Blue Razz Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Dippin' Dots Banana Split Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Charms Blow Pop Sour Apple Hand Gel (NingBo Huize) – Manufacturing Deviation (2019)

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

FDAApr 1, 2019IN• NingBo Huize Commodity Co.,Ltd.

Breads from Anna Black Bean Brownie Mix (Wholesome) – undeclared flaxseed (2019)

Undeclared Allergen

Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.

FDAMar 31, 2019Nationwide• Wholesome Treats, Inc.

Breads from Anna Classic Herb Mix (Wholesome) – undeclared flaxseed (2019)

Undeclared Allergen

Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.

FDAMar 31, 2019Nationwide• Wholesome Treats, Inc.

Breads from Anna Dairy & Corn Free Mix (Wholesome) – undeclared flaxseed (2019)

Undeclared Allergen

Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.

FDAMar 31, 2019Nationwide• Wholesome Treats, Inc.

Breads from Anna Yeast Free Mix (Wholesome) – undeclared flaxseed (2019)

Undeclared Allergen

Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.

FDAMar 31, 2019Nationwide• Wholesome Treats, Inc.

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