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Food & drugs

Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks

10-08-2017

Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.

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Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance

10-08-2017

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

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Schnucks Bakery Issues Allergy Alert on Undeclared Pecans in German Chocolate Cake Labeled as “Schnucks Bakery Deluxe Petite Ca

09-08-2017

Schnucks Bakery, a St. Louis, Mo. establishment, is issuing an allergy alert on 13 German Chocolate Cakes labeled as “Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow” that contain pecans that are not listed on the ingredient label....

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Taylor Farms Retail, Inc. Recalls Coleslaw Kits Due To Undeclared Milk Allergen

08-08-2017

Taylor Farms Retail, Inc. in Salinas is conducting a limited recall of 293 cases of Taylor Farms Creamy Homestyle Coleslaw Kits due to an undeclared milk allergen. Milk is an ingredient in the dressing packet included in the salad kit. This recall...

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The Comfy Cow Recalls Pints of Ice Cream Due To Possible E. Coli Contamination and/or High Coliform Counts

08-08-2017

The Comfy Cow is recalling pints of Banana Puddin Y’all, Chocolate Squared2, Cookies and Cream, Cow Trax, Double Fold Vanilla, Georgia Butter Pecan, Intense Dark Chocolate, Salted Caramel, Strawberry Fields Forever due to a potential contamination...

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Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisor

08-08-2017

Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.

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Freshtex Produce Recalls “Valery” Brand Maradol Papayas Due to Possible Health Risk

07-08-2017

Freshtex Produce of Alamo, TX is voluntarily recalling “Valery” brand Maradol Papayas grown and packed by Carica de Campeche, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes...

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Agroson’s LLC Recalls Maradol Papaya Cavi Brand Grown and Packed by Carica De Campeche Because of Possible Health Risk

05-08-2017

Agroson’s LLC of Bronx, NY is recalling 2,483 boxes of Maradol Papaya Cavi Brand, grown and packed by Carica de Campeche, as a precaution because other brands that also buy from this farm have been tested positive for Salmonella, an organism which...

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Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

04-08-2017

Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.

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System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Co

04-08-2017

UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy.

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Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Us

04-08-2017

Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.

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Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

03-08-2017

Use could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

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