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Showing 4701–4720 of 29086 results

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Common Sense Hand Sanitizer (Aire-Master) – Water Contamination (2022)

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class IIModerate

FDAJul 15, 2022FL, IL, IA +1 more• Aire-Master of America Inc

Protect U Guard Hand Sanitizer (Aire-Master) – Water Quality Concerns (2022)

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class IIModerate

FDAJul 15, 2022FL, IL, IA +1 more• Aire-Master of America Inc

Protect U Guard Hand Sanitizer (Aire-Master) – Manufacturing Deviation (2022)

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class IIModerate

FDAJul 15, 2022FL, IL, IA +1 more• Aire-Master of America Inc

Organic Blueberries (Natierra) – elevated lead (2022)

Elevated levels of lead detected as a result of testing conducted by Maryland Department of Health.

Class IIModerate

FDAJul 15, 2022Nationwide• BrandStorm Inc

Avant Hand Sanitizer (Aire-Master) – Water Contamination (2022)

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class IIModerate

FDAJul 15, 2022FL, IL, IA +1 more• Aire-Master of America Inc

Stage 2 Ophardt Hand Sanitizer (Aire-Master) – Production Flaw (2022)

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class IIModerate

FDAJul 15, 2022FL, IL, IA +1 more• Aire-Master of America Inc

Magnesium Citrate (Vi-Jon) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJul 15, 2022Nationwide• Vi-Jon, LLC

Truffle Arancini (Kabobs Acquisition) – glass contamination (2022)

The firm was notified by their rice supplier that the product may contain small pieces of glass.

Class IIModerate

FDAJul 14, 2022GA, IL, KY +7 more• Kabobs Acquisition Inc.

Tomato Basil Arancini (Kabobs Acquisition) – glass contamination (2022)

The firm was notified by their rice supplier that the product may contain small pieces of glass.

Class IIModerate

FDAJul 14, 2022GA, IL, KY +7 more• Kabobs Acquisition Inc.

Difluprednate Ophthalmic Emulsion (CIPLA) – Container Defect (2022)

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Class IIModerate

FDAJul 14, 2022Nationwide• CIPLA

Tomato Vegetable Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Caramelized Onion & Goat Cheese Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Shrimp & Asparagus Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Sweet Pea Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Summertime Filet Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Vegan Mushroom Marsala Risotto (FACTOR) – glass risk (2022)

Products contain an arborio rice ingredient that was recalled by the supplier because it contains glass

Class IIModerate

FDAJul 14, 2022Nationwide• FACTOR

Lansoprazole Orally Disintegrating Tablets 35mg (Dr. Reddy's) – Dissolution Failure (2022)

FAILED DISSOLUTION SPECIFICATIONS

Class IIModerate

FDAJul 13, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Lansoprazole Orally Disintegrating Tablets 15mg (Dr. Reddy's) – Dissolution Failure (2022)

FAILED DISSOLUTION SPECIFICATIONS

Class IIModerate

FDAJul 13, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Arborio Rice (Woodland Foods) – glass pieces (2022)

possible presence of glass pieces

Class IIModerate

FDAJul 13, 2022AZ, CA, CT +20 more• Woodland Foods LLC

Children's Botanicals Nighttime (P&G) – unapproved process (2022)

Acidified/Low Acid dietary supplement with no approved process.

Class IIModerate

FDAJul 12, 2022AL, AK, AZ +42 more• The Procter & Gamble Company

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