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Food & drugs

Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism

06-02-2018

FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.

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Kanan Enterprises Conducts Voluntary Recall of Southern Grove Unsalted Almond Due to Undeclared Wheat and Soy

06-02-2018

Kanan Enterprises announces the voluntary recall of Southern Grove Unsalted Almond 14 oz., Best By SEP 25 2018 KN due to the presence of wheat and soy that are not listed as ingredients. People who have an allergy to wheat or soy run the risk of a...

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Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination

02-02-2018

Probability of a potentially sight threatening eye infection or impairment.

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JFC International Inc. Issues Allergy Alert on Undeclared Crustacean Shellfish (Shrimp, Crab) in Daisho Kimchi Hot Pot Soup Bas

02-02-2018

JFC International Inc. of Los Angeles, CA is voluntarily recalling a Kimchi Hot Pot Soup Base because it was found to contain undeclared Crustacean Shellfish (Shrimp, Crab). Individuals who have allergies to crustacean shellfish (shrimp, crab)...

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Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product C

01-02-2018

Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial...

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Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

01-02-2018

FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.

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AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error

31-01-2018

Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.

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Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use

30-01-2018

Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.

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Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

30-01-2018

UPDATED 01/30/2018. Primus voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level.

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Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But

29-01-2018

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible...

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Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products

29-01-2018

While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated...

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Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement

25-01-2018

Out of an abundance of caution, Bulletproof 360, Inc. is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of...

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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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