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Showing 201–220 of 470 results

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Delflex Peritoneal Dialysis Solution (Fresenius) – Tube Weld Failure (2024)

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Class IIModerate

FDAJun 18, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Suntegrity Sunscreen (Synchronicity) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Sicilian Semolina (Della Fattoria) – undeclared sesame (2024)

Missing the declaration of sesame seeds from the "Contains" statement.

Class IIModerate

FDAMay 8, 2024CA• Della Fattoria, LLC

Della Fattoria Seeded Wheat – Missing Sesame Declaration (2024)

Missing the declaration of sesame seeds from the "Contains" statement.

Class IIModerate

FDAMay 8, 2024CA• Della Fattoria, LLC

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Aloe Gator Sunscreen (ARG Laboratories) – Ingredient Specification (2024)

Out of Specification for active ingredient

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Bull Frog Sunscreen (ARG Laboratories) – Active Ingredient Issue (2024)

Out of Specification for active ingredient

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Golden Tiger Pain Cream (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Pain Wizard (ARG Laboratories) – Active Ingredient Violation (2024)

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Class IIModerate

FDAApr 17, 2024Nationwide• ARG Laboratories, Inc.

Fentanyl Citrate (IntegraDose) – Sterility Risk: Leaking (2024)

Lack of Assurance of Sterility: leaking bags

Class IIModerate

FDAMar 22, 2024Nationwide• IntegraDose Compounding Services LLC

TRP Red Eye Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

Pink Eye Relief Eye Drops (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

TRP Aging Eye Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

TRP Eye Strain Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

TRP Dryness Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

TRP Natural Eyes Floaters Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

TRP Blur Relief (Optikem) – sterility risk (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 29, 2024Nationwide• Optikem International, Inc.

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