All recalls8,436 total
Potential to be contaminated with Listeria monocytogenes
Potential to be contaminated with Listeria monocytogenes
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lack of Assurance of Sterility
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)
Leaking induction seal on packaging.
Product labeled to be Zero Sugar contains full sugar product.
Leaking induction seal on packaging.
Leaking induction seal on packaging.
Presence of foreign tablets/capsules.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Cucumbers have the potential to be contaminated with Salmonella
Cucumbers have the potential to be contaminated with Salmonella
Product has potential contamination with Salmonella
Cucumbers have the potential to be contaminated with Salmonella
Product has Salmonella contamination
Salmonella. Greek Salad products were made with recalled cucumbers from Bedner Grower's Company which are contaminated with Salmonella and implicated in an ongoing outbreak.
Product has Salmonella contamination
Cucumbers have the potential to be contaminated with Salmonella
Product has Salmonella contamination
Product has Salmonella contamination
Product has Salmonella contamination
Undeclared Milk Allergen
Contaminated with Salmonella
Salmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and implicated in an ongoing outbreak.
Cucumbers have the potential to be contaminated with Salmonella
Contains cucumber contaminated with Salmonella recalled by Bedner Growers Inc.
Salmonella. The firm received cucumbers produced by Bedner Farms.
Cucumbers have the potential to be contaminated with Salmonella
Cucumbers have the potential to be contaminated with Salmonella
Cucumbers have the potential to be contaminated with Salmonella
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Lack of Assurance of Sterility
Lack of Assurance of Sterility