Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK ® 15 Monitor/Defibrillator
The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 1, 2019 Category: Food Science Source Type: news
Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK ® 15 Monitor/Defibrillator
The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 1, 2019 Category: Food Science Source Type: news
FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.
Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 1, 2019 Category: American Health Source Type: news
Hill ’ s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D
Hill ’ s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products ...
Source: Food and Drug Administration - January 31, 2019 Category: Food Science Source Type: news
Hill ’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D
Hill ’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of expos ure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consu med any of the products...
Source: Food and Drug Administration - January 31, 2019 Category: Food Science Source Type: news
Hill ’ s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D
Hill ’ s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products ...
Source: Food and Drug Administration - January 31, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines
FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: American Health Source Type: news
FDA approves first generic Advair Diskus
FDA approved the first generic of Advair Diskus for treatment of asthma and maintenance treatment of airflow obstruction and reducing exacerbations with COPD. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: American Health Source Type: news
Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen
Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: Food Science Source Type: news
Nature ’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDE-5 Inhibitors in the Product
Nature ’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectiv ely, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: Food Science Source Type: news
Nature ’ s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product
Nature ’ s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’ s efforts to enhance the utility of the Orange Book to foster drug competition
FDA announces new policies to ensure the Orange Book provides the greatest benefit to patients and providers, and generic drug developers. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s efforts to enhance the utility of the Orange Book to foster drug competition
FDA announces new policies to ensure the Orange Book provides the greatest benefit to patients and providers, and generic drug developers. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: American Health Source Type: news
Purina Animal Nutrition Voluntarily Recalling Purina ® Honor ® Show Chow ® Showlamb Grower Due to Elevated Copper Level
) – Purina Animal Nutrition is voluntarily recalling two lots of Purina ® Honor ® Show Chow ® Showlamb Grower due to elevated copper levels. The feed is packaged in purple branded Purina Honor Show Chow bags. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 29, 2019 Category: Food Science Source Type: news
Purina Animal Nutrition Voluntarily Recalling Purina ® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level
) – Purina Animal Nutrition is voluntarily recalling two lots of Purina® Honor® Show Chow® Showlamb Grower due to elevated copper levels. The feed is packaged in purple branded Purina Honor Show Chow bags. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 29, 2019 Category: Food Science Source Type: news
