FDA Recalls Week of January 7, 2018

Fieldbrook Foods Corporation, Announces An Extension of Voluntary Recall of Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars for Possible Health Risk—January 9, 2018

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.

For merchants/brands to look out for, check out the Official FDA Recall Notification here.

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall — Product Mislabeling—January 10, 2018

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.

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life-threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life-threatening.

Read the rest of the official recall here.

Certitude Delivery System by Edwards Lifesciences: Class I Recall — Mold Overflow Defect Which May Obstruct Blood Flow—January 11, 2018

Edwards LifeSciences is recalling its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. The overflow material could detach during placement of the delivery system and potentially embolize into the patient.

Such an embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. In dire situations, severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.

Read the rest of the recall here.

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance—January 11, 2018

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. To date, PharMEDium has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.

Read why the recall was expanded here.

Fieldbrook Foods Corporation Clarifies Scope of its Voluntary Recall. Products Include Orange Cream—January 11, 2018

Fieldbrook Foods Corporation is clarifying that the previously announced 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) also includes 28,751 cases of Raspberry Cream Bars that were included with Orange Cream Bars in ALDI seasonal split-case purchases. The split-cases were shipped between March and August 2017. These 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.

Read the rest of the official recall announcement here.

Hom/Ade Foods, Inc. Voluntary Recalls Frozen Biscuits Because of Possible Health Risk—January 11, 2018

Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product. Listeria monocytogenes is 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.

Read the official announcement here.