The FDA's Recall Week:One Half Billion Eggs, Moonstruck Chocolate and Mr. Magic Male Enhancer
It was a busy week for the US Food and Drug Administration. Recalls (voluntary and otherwise) ranged from a male enhancer, frozen mamey pulp, the withdrawal of a low blood pressure drug, the approval of tablets for emergency contraception, and recalling those half billion eggs. And for special programs:
- Food Facts
Includes flyers on Dietary Supplements, Egg Safety, Food Allergies, Bottled Water, Produce Safety, Seafood Safety, Ready-to-Eat Refrigerated Foods, Raw Milk, and more - Food Safety & Nutrition Education Campaigns
Includes education campaigns for kids & teens, for pregnant women, for Hispanic Community, tools for educators, and more.
By the way, if you'd like to sign up for FDA alerts and recalls, you can. This week's action list promises even more egg recalls.
Message: 1From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 07:14:48 -0500 (CDT)
Subject: FDA approves ella[TM] tablets for prescription emergency contraception
FDA approves ella[TM] tablets for prescription emergency contraception
Fri, 13 Aug 2010 16:05:00 -0500
The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
Message: 2
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 07:17:30 -0500 (CDT)
Subject: Goya Foods, Inc. Announces Voluntary Recall of Frozen Mamey Pulp, Produced By Coco, S.A. of Guatemala Because of Potential Health Risk
Fri, 13 Aug 2010 22:47:00 -0500
As a precautionary measure Goya Foods, Inc. has voluntarily recalled the Mamey Pulp product produced by COCO, S.A. of Guatemala. This product is distributed nationwide through retail stores under the Goya label.
Message: 3
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 07:18:10 -0500 (CDT)
Subject: Wright County Egg Conducts Nationwide Voluntary Recalls of Shell Eggs Because of Possible Health Risk
Wright County Egg Conducts Nationwide Voluntary Recalls of Shell Eggs Because of Possible Health Risk
Fri, 13 Aug 2010 22:45:00 -0500
The following statement was released by officials of Wright County Egg regarding the US Food and Drug Administration’s (FDA) on-farm records review and egg testing for Salmonella. Wright County Egg of Galt, Iowa is voluntarily recalling specific Julian dates of shell eggs produced by their farms because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Message: 4
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 11:52:36 -0500 (CDT)
Subject: Drug Information Update: FDA Proposes Withdrawal of Low Blood Pressure Drug
The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.
For more information please visit: Midodrine
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
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Message: 5
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 12:21:18 -0500 (CDT)
Subject: Drug Information Update - FDA approves ella™ tablets for prescription emergency contraception
The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.
For more information, please visit: Ella
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
Message: 6
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 12:53:24 -0500 (CDT)
Subject: FDA Proposes Withdrawal of Low Blood Pressure Drug
FDA Proposes Withdrawal of Low Blood Pressure Drug
Mon, 16 Aug 2010 11:23:00 -0500
The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
Message: 7
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, 17 Aug 2010 06:29:51 -0500 (CDT)
Subject: Nationwide Milk Allergen Recall of Kroger "Meals Made Simple Shrimp Linguini"
Nationwide Milk Allergen Recall of Kroger "Meals Made Simple Shrimp Linguini"
Mon, 16 Aug 2010 17:02:00 -0500
Kroger (product distributor) and Contessa Premium Foods, Inc. (product manufacturer) are recalling 24 ounce bags of Kroger brand Meals Made Simple Shrimp Linguini, because it may contain undeclared milk product. People who have an allergy or severe sensitivity to milk products run the risk of serious or life-threatening allergic reaction if they consume this product.
Message: 8
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, 17 Aug 2010 06:30:54 -0500 (CDT)
Subject: Staphylococcus Aureus in Queso Cotija Cheese
Staphylococcus Aureus in Queso Cotija Cheese
Mon, 16 Aug 2010 14:38:00 -0500
New York State Agriculture Commissioner Patrick Hooker today warned consumers in the Queens County, New York area not to consume certain “Queso Cotija Cheese” made by Mexicali Cheese Corp, 91-52 87th Street, Woodhaven, New York 11421 due to possible Staphylococcus aureus contamination.
Message: 9
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, 17 Aug 2010 06:34:52 -0500 (CDT)
Subject: Merrick Pet Care Recalls Filet Squares & Texas Hold'ems 10oz Bag (Item # 60016 All Lots) Because of Possible Salmonella Health Risk
Mon, 16 Aug 2010 13:25:00 -0500
Merrick Pet Care, Inc. of Amarillo, Texas is recalling all lots of its 10 oz “Beef Filet Squares” for Dogs and “Texas Hold’ems” pet treats because they have the potential to be contaminated with Salmonella. Salmonella can affect animals and there is risk to humans from handling contaminated pet products. People handling the treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the chews or any surfaces exposed to these products.