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Showing 3801–3820 of 4465 results

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Zaarah Bhringraj Powder – Heavy Metal Contamination (2025)

Products contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm;

Class IHigh

FDAMar 10, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

Zaarah Rasayan Churan – Elevated Lead (2025)

Products contain elevated levels of Lead (Pb): 88.038 ppm

Class IHigh

FDAMar 10, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Moderate

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

Philips DXR System (Philips) – collimator fall risk (2025)

Potential for collimator to fall as a result of incorrect installation.

Moderate

FDAMar 10, 2025Nationwide• Philips North America Llc

VH-3010 Power Supply (Maquet) – resistor issue (2025)

Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the Jaws of the HemoPro 2 to not adequately head up.

Moderate

FDAMar 10, 2025Nationwide• Maquet Cardiovascular, LLC

TLX/TLC Implant Driver (Straumann) – depth marking missing (2025)

The devices are missing the laser marked depth markings.

Low

FDAMar 8, 2025Nationwide• Straumann USA LLC

PROLENE BLU 18IN (Ethicon Endo Surgery) – Manufacturing Curing Issues (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

Forest River Aurora (Forest River) – air conditioner connector (2025)

Fire/Burn Risk

Forest River, Inc. (Forest River) is recalling certain 2025 Aurora ART26BHS travel trailers. The electrical connector for the air conditioner may have strands of wiring exposed, which can cause electrical arcing.

High

NHTSAMar 7, 2025Nationwide• FOREST RIVER

Mercedes-Benz EQE (Mercedes-Benz) – wheel rim detachment (2025)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2023 EQE 350 4MATIC and EQE 350+ vehicles. The rim inserts may detach from the wheels while driving.

High

NHTSAMar 7, 2025Nationwide• MERCEDES-BENZ

Ethibond Excel Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

PDS Plus Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

PDS II Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

Hydrogen Peroxide Solution (Consumer Product) – Label Mixup (2025)

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Class IIModerate

FDAMar 7, 2025VA• Consumer Product Partners, LLC

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Sodium Bicarbonate Injection (Exela Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2025Nationwide• Exela Pharma Sciences LLC

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAMar 7, 2025Nationwide• Direct Rx

Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Class IIModerate

FDAMar 7, 2025Nationwide• ASEGUA THERAPEUTICS LLC

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