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Showing 2961–2980 of 11714 results

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Shatavari Powder (Zaarah Herbals) – Lead Contamination (2025)

Product contains elevated levels of lead - 6.50 mg/kg (ppm)

FDAJan 27, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

MiniDock Nucleic Acid Device (Pluslife) – FDA authorization (2025)

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

FDAJan 24, 2025Nationwide• Guangzhou Pluslife Biotech Co., Ltd.

SARS-CoV-2 Test Card (Pluslife) – FDA authorization (2025)

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

FDAJan 24, 2025Nationwide• Guangzhou Pluslife Biotech Co., Ltd.

HydrALAZINE 50mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

HydrALAZINE 25mg Tablets (SKY) – Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 24, 2025Nationwide• SKY PACKAGING

BD Pyxis MedFlex (CareFusion) – scanner overheating (2025)

Due to fingerprint scanner failing resulting in the scanner heating up.

FDAJan 23, 2025Nationwide• CareFusion 303, Inc.

Lumenis Pulse Laser System (Lumenis) – charger overheating (2025)

The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.

FDAJan 23, 2025PA• LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel

BD Alaris Pump Module (CareFusion) – safety clamp error (2025)

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

FDAJan 23, 2025AL, AK, AZ +47 more• CareFusion 303, Inc.

Timolol Maleate Eye Solution (FDC) – Defective Container (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAJan 23, 2025IN, NJ• FDC Limited

Carvedilol Tablets 25mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

A.L.P.S. Anatomic Fibula Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

A.L.P.S. Lateral Fibula Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

LIFEPAK 15 Masimo Sensors (Physio-Control) – sensor error (2025)

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

A.L.P.S. Medial Tibia Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Phenylephrine Injection (Provepharm) – Particulate Matter (2025)

Presence of Particulate Matter.

FDAJan 21, 2025Nationwide• Provepharm Inc.

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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