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Showing 201–220 of 548 results

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New Orleans Hot Mix (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Dried Mangos with Chili (Cal Yee) – undeclared color (2024)

Undeclared Allergen

Undeclared yellow #5

Class IIModerate

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Cajun Sesame Hot Sticks (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

Class IHigh

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Diced Bartlett Pears (Pacific Coast Producers) – Foreign Objects (2024)

Potential contamination with foreign objects.

Class IIModerate

FDADec 5, 2024KY, MI, OH +1 more• Pacific Coast Producers

Organic Pecan Halves (Pecan Star) – Undeclared Walnuts (2024)

Undeclared Allergen

Undeclared walnuts

Class IIModerate

FDADec 4, 2024AL, FL, GA +5 more• Pecan Star & Nut Corp.

Gelato Benzocaine Topical Gel (Keystone) – Manufacturing Defect (2024)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Class IIModerate

FDANov 14, 2024Nationwide• Keystone Industries

Ipana Topical Gel (Keystone Industries) – CGMP Vessel Defect (2024)

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Class IIModerate

FDANov 14, 2024Nationwide• Keystone Industries

L'Oven Fresh Keto Original Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

Class IIModerate

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

L'Oven Fresh Keto Multiseed Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

Class IIModerate

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

Diabetics Foot Cream (Brands International) – Inadequate Testing (2024)

CGMP Deviations: lack of adequate release testing.

Class IIModerate

FDANov 13, 2024Nationwide• Brands International Corporation

Docusate Sodium Softgel (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class IIModerate

FDANov 11, 2024Nationwide• Safecor Health, LLC

Germ Away Antibacterial Hand Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Boardwalk Antibacterial Handsoap Refill (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Maxim Assure Antibacterial Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Compliance Dishwashing Liquid Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Genuine Joe Antibacterial Lotion Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Nestle Nutren 2.0 (Nestle Health Science) – Labeling Error (2024)

Labeling Error. Nutren 2.0 UltraPak pouches were mislabeled with an Isosource 1.5 label.

Class IIModerate

FDANov 5, 2024AZ, CA, FL +13 more• NESTLE HEALTH SCIENCE

Jarritos Coconut Water – Seal Compromise (2024)

The hermetic seal on the lid of the cans may be compromised

Class IIModerate

FDANov 4, 2024AL, AR, DE +26 more• Tipp Distributors, Inc. dba Novamex

LICEOUT Treatment (Neogen) – CGMP Violation (2024)

CGMP violations.

Class IIModerate

FDAOct 8, 2024Nationwide• Neogen Corporation

LICEOUT Treatment (Neogen) – CGMP Violation (2024)

CGMP violations.

Class IIModerate

FDAOct 8, 2024Nationwide• Neogen Corporation

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