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Showing 5881–5900 of 92420 results

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Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Guaifenesin Dextromethorphan Syrup (Harvard Drug Group) – Specification Failure (2024)

Failed Impurity/Degradation Specifications

Class IIModerate

FDANov 7, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Major Neuro Pack Convenience Kit (Medline) – Endotoxin Level (2024)

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

FDANov 6, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

ChemoLock Vial Spike (ICU Medical) – Packaging Error (2024)

Due to finished goods incorrectly packaged and labeled.

FDANov 6, 2024Nationwide• ICU Medical, Inc.

2025 PJ Trailers LD (PJ Trailers) – Suspension Brake Issue (2024)

PJ Trailers is recalling certain 2024-2025 LD trailers. The air ride suspension brake axles may be installed incorrectly, resulting in reduced braking ability.

NHTSANov 6, 2024Nationwide• PJ TRAILERS

FESS-MB Pack Convenience Kit (Medline) – Endotoxin Level (2024)

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

FDANov 6, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Falken WildPeak AT4W Tire (Falken) – Sidewall Manufacturing Issue (2024)

Sumitomo Rubber USA, LLC (Sumitomo) is recalling certain Falken WildPeak AT4W size 275/60R20 115T tires. The tires may have been produced using the incorrect cord material for one of the plies. The sidewall label incorrectly identifies the generic name of the cord material. As such, the affected tires do not meet the labeling requirements of Federal Motor Vehicle Safety Standard number 139, New pneumatic radial tires for light vehicles.

NHTSANov 6, 2024Nationwide• FALKEN

Merlin.net PCN Heart Failure Web App (St. Jude) – Data Migration Issue (2024)

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

FDANov 6, 2024CA, CT, GA +10 more• St. Jude Medical

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more• Abbott Vascular Inc

BD BBL Sensi Disc Ampicillin (Becton Dickinson) – Potency Decrease (2024)

BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility

FDANov 6, 2024Nationwide• Becton Dickinson & Co.

Spine LH Convenience Kit (Medline) – Endotoxin Level (2024)

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

FDANov 6, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Abbott 20/30 Indeflator (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more• Abbott Vascular Inc

Septoplasty Pack Convenience Kit (Medline) – Endotoxin Level (2024)

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

FDANov 6, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Abbott 20/30 Priority Pack Kit (Abbott) – Inflation Device Leak (2024)

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

FDANov 6, 2024AL, AZ, AR +37 more• Abbott Vascular Inc

Trinity Gold Nutrition Capsules (Trinity Gold) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.

Class IIModerate

FDANov 6, 2024Nationwide• Trinity Gold Nutrition

Bevacizumab Sterile Injection (Tailstorm Health) – Sterility Concern (2024)

Lack of Sterility Assurance

Class IIModerate

FDANov 6, 2024Nationwide• Tailstorm Health INC

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

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

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