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Showing 5501–5520 of 29086 results

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Losartan Potassium Tablets 100mg (Lupin) – AZIDO Impurity Excess (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMar 31, 2022Nationwide• Lupin Pharmaceuticals Inc.

Losartan Potassium Tablets 25mg (Lupin) – AZIDO Impurity Excess (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMar 31, 2022Nationwide• Lupin Pharmaceuticals Inc.

Losartan/Hydrochlorothiazide 100/25mg (Lupin) – AZIDO Impurity Excess (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAMar 31, 2022Nationwide• Lupin Pharmaceuticals Inc.

SKIPPY Peanut Butter Blended with Plant Protein (Skippy) – steel contaminants (2022)

Potential to contain small steel contaminants.

Class IIModerate

FDAMar 30, 2022CA, CT, DE +18 more• Skippy Foods, LLC.

Suave Antiperspirant Fresh (Unilever) – Benzene Contamination (2022)

CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

Class IIModerate

FDAMar 30, 2022Nationwide• Unilever United States Inc.

SKIPPY Chunky Peanut Butter – steel contamination (2022)

Potential to contain small steel contaminants.

Class IIModerate

FDAMar 30, 2022CA, CT, DE +18 more• Skippy Foods, LLC.

SKIPPY Creamy Peanut Butter – steel contamination (2022)

Potential to contain small steel contaminants.

Class IIModerate

FDAMar 30, 2022CA, CT, DE +18 more• Skippy Foods, LLC.

Lansoprazole Solution (Preferred Pharmaceuticals) – Stability Failure (2022)

Out of specification results observed in dissolution during long term stability testing.

Class IIModerate

FDAMar 28, 2022Nationwide• Preferred Pharmaceuticals, Inc.

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Deviation (2022)

CGMP Deviations: Failure to properly investigate failed microbial testing.

Class IIModerate

FDAMar 24, 2022IN• Plastikon Healthcare LLC

Diclofenac Sodium Topical Solution (Preferred Pharmaceuticals) – Stability Study Discontinuation ...

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Class IIModerate

FDAMar 24, 2022Nationwide• Preferred Pharmaceuticals, Inc.

Econazole Nitrate Cream (Preferred Pharmaceuticals) – Stability Study Discontinuation (2022)

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Class IIModerate

FDAMar 24, 2022CA, FL, IN• Preferred Pharmaceuticals, Inc.

Milk of Magnesia (Plastikon) – Microbial Testing Failure (2022)

CGMP Deviations: Failure to properly investigate failed microbial testing.

Class IIModerate

FDAMar 24, 2022IN• Plastikon Healthcare LLC

Magnesium Hydroxide Suspension (Plastikon) – Microbial Testing Failure (2022)

CGMP Deviations: Failure to properly investigate failed microbial testing.

Class IIModerate

FDAMar 24, 2022IN• Plastikon Healthcare LLC

Align Digestive De-Stress Capsules (Procter & Gamble) – micro testing failure (2022)

Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store.

Class IIModerate

FDAMar 24, 2022Nationwide• The Procter & Gamble Company

Wilton Chocolate Cookie Bunny Hutch Kit (Wilton) – undeclared milk (2022)

Milk is missing from the product's allergen Contains statement

Class IIModerate

FDAMar 24, 2022Nationwide• Wilton Industries Inc

Mint Macaron (Elegant Foods) – Undeclared Colors (2022)

Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.

Class IIModerate

FDAMar 23, 2022WI• Elegant Foods, LLC

Elegant Foods Macaron Variety A (Elegant Foods) – undeclared colors (2022)

Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.

Class IIModerate

FDAMar 23, 2022WI• Elegant Foods, LLC

Fall Spice Macaron (Elegant Foods) – Undeclared Colors (2022)

Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.

Class IIModerate

FDAMar 23, 2022WI• Elegant Foods, LLC

Raspberry Macaron (Elegant Foods) – Undeclared Colors (2022)

Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.

Class IIModerate

FDAMar 23, 2022WI• Elegant Foods, LLC

Elegant Foods Passion Fruit Mango Macaron (Elegant Foods) – undeclared colors (2022)

Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.

Class IIModerate

FDAMar 23, 2022WI• Elegant Foods, LLC

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