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Food & drugs

Tesoros Trading Company Recalls Product Because of Possible Health Risk

17-12-2020

Tesoros Trading Co. from Las Vegas, NV is recalling certain codes of frozen “Trader Joe’s Lightly Salted Edamame” because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes...

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Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious

15-12-2020

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke...

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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

09-12-2020

Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

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AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

09-12-2020

AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products...

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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

09-12-2020

Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

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AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

09-12-2020

AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products...

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George DeLallo Co., Inc. Issues Allergy Alert on Undeclared Pecans in 20 oz Publix Bakery Holiday Cookie Platters

07-12-2020

George DeLallo Co., Inc. of Mt. Pleasant, PA is recalling Publix Bakery 20 OZ Holiday Cookie Platters because they may contain undeclared pecans. People who have allergies to pecans run the risk of serious or life-threatening allergic reaction if...

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Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication

07-12-2020

The FDA is informing of a potential for injury during MRI while wearing a face mask that contains metal (such as surgical or non-surgical masks and respirators).

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2020 Safety Communications

07-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

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Market of Choice Issues Allergy Alert on Undeclared Almonds in Sour Cherry Baked Brie

05-12-2020

Market of Choice of Eugene, Oregon, is recalling its in-house Sour Cherry Baked Brie because of undeclared almonds.

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UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of

04-12-2020

The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2).

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2020 Safety Communications

04-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

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Food & drugs

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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