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Showing 1061–1080 of 3039 results

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DermaFungal (DermaRite) – CGMP contamination risk (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Dilly Pickle Monterey Jack Cheese (Sunrise Creamery) – listeria contamination (2025)

Potential contamination with Listeria monocytogenes

FDAAug 27, 2025OH, PA, TX +1 more• Middlefield Original Cheese Cooperative

DermaKleen Antiseptic Soap (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

4-N-1 Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

PeriGiene Antiseptic (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

DermaCerin Moisturizing Cream (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

PeriGuard Ointment (DermaRite) – CGMP contamination risk (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Succinylcholine Chloride Injection (Zydus) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

Class IIModerate

FDAAug 27, 2025LA, MS, OH +1 more• Zydus Pharmaceuticals (USA) Inc

DermaMed Skin Ointment (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Lantiseptic Dry Skin Therapy (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

San-E-Foam Alcohol Sanitizer (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Shredded Mozzarella Cheese (Middlefield) – listeria contamination (2025)

Potential contamination with Listeria monocytogenes

FDAAug 27, 2025OH, PA, TX +1 more• Middlefield Original Cheese Cooperative

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Mild Cheddar Cheese (Middlefield) – listeria contamination (2025)

Potential contamination with Listeria monocytogenes

FDAAug 27, 2025OH, PA, TX +1 more• Middlefield Original Cheese Cooperative

Lantiseptic Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

KleenFoam Antimicrobial Soap (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

McKesson Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

AlignRT InBore System (Vision RT) – Laser Information Omission (2025)

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

FDAAug 27, 2025Nationwide• Vision RT Ltd Dove House Arcadia Avenue London United Kingdom

Monterey Jack Cheese (Middlefield) – listeria contamination (2025)

Potential contamination with Listeria monocytogenes

FDAAug 27, 2025OH, PA, TX +1 more• Middlefield Original Cheese Cooperative

Renew Skin Repair Cream (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

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