Category Archives: Food & Drug Recalls

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

Gilster – Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating

January 8, 2018 – Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling one lot of Essential Everyday® Coat & Bake Original Chicken coating, UPC 41303-01572 at the consumer level because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use

The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in bottles of 30 tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Fieldbrook Foods Corporation, Announces an Extension of Voluntary Recall of Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars for Possible Health Risk

Fieldbrook Foods Corporation has issued a voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677). This is the only production line and the only Fieldbrook Foods plant (of 3) involved in this recall notice. Both products are being recalled due to the possibility that they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Dollar General Announces Voluntary Recall of Clover Valley® Iced Oatmeal Cookies Over Undeclared Milk and Tree Nuts

Dollar General Corporation announced a voluntary recall of its 12-ounce packages of Clover Valley® Iced Oatmeal Cookies with lot # L46217 30 with a best-by date of August 18, 2018 over concerns of undeclared milk and tree nuts. Consumers with a milk and/or nut allergy or sensitivity to these items should not consume these products due to a possible health risk or serious allergic reaction. No illnesses or reactions have been reported at this time.
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Fieldbrook Foods Corporation, Announces a Voluntary Recall of Orange Cream Bars for Possible Health Risk

Fieldbrook Foods Corporation of Dunkirk NY has issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.