We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week.
We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week:
Living Well Remedies Recalls Weight Away Remedy Due to Microbial Contamination
Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.
Weight Away Remedy is a homeopathic spray that can help with weight loss and is packaged in a 2 oz spray bottle. Weight Away Remedy lot # 111417LWL614 was purchased over the internet by 101 consumers and should be discarded.
Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. Living Well Remedies, LLC has not received any consumer complaints or reports of adverse events related to this recall.
For more details on this recall, check out the announcement.
Accord Healthcare Recalls Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Error
Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 — 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.
Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.
Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Accord’s Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.
For additional information on this recall, consult the company announcement.
King Bio Expands Recall to Include All Aqueous-Based Products Due to Possible Contamination
King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.
Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life-threatening to certain individuals. To date, King Bio has not received any reports of illness or injury. King Bio is recalling the products listed on the website link below as a precautionary measure.
A complete list of recalled products and lot numbers can be found at this website.
In a separate statement, the FDA said:
“The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.”
For more information on this recall expansion, check out the news release.
Haemonetics Corporation Recalls 10 Lots of Leukotrap RC System with RC2D Filter
Haemonetics has received reports of higher than expected residual WBC associated with the lot numbers of Leukotrap RC Systems with RC2D Filter listed in the table. Haemonetics has identified that this issue arises from a manufacturing assembly issue related to a single RC2D filter lot (a subcomponent of the Leukotrap RC System).
Use of these lots may result in a higher than expected level of leukocytes in transfused blood.
Please discontinue the use of these lots and return any unused product to Haemonetics. Haemonetics will replace these recalled product lots. Contact your local customer service representative at the number below to coordinate the return and the shipment of replacement product to ensure a seamless exchange of goods.
The affected product lots were shipped to firms between April 2018 and July 2018.
For more information on this recall, check out the statement.
Product Quest Manufacturing Recalls Nasal Products and Baby Oral Gel Products Due to Possible Microbial Contamination
Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility.
There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. This recall should be carried out to the retail level.
Risk Statement: Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life-threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life-threatening in certain patient populations, including babies or very young children. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date.
For a list of all products affected by this recall, consult the statement.
Olufela Yemitan Recalls Siluriformes Products Distributed Without Benefit of Import Inspection
Olufela Yemitan, the Importer of Record, a Houston, Texas firm, is recalling approximately 45 pounds of smoked Siluriformes products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The dried, smoked Siluriformes items were produced during the month of August 2018. The following products are subject to recall:
The products were imported from Nigeria, a country that is not eligible to export Siluriformes to the United States. These items were shipped to retail distribution locations in Texas.
For more information on this recall, read the USDA’s statement.
Hellolife Inc, Recalls Products Due to Possible Microbial Contamination
HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia.
Compulsin has been identified as containing Burkholderia cepacia.
Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.
For a complete list of recalled products, check out the recall announcement.
Pfizer Inc, Issues Recall of One Lot of Children’s Advil Due to Unmatched Dosage Cup That Could Lead to Potential Overdose
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).
Pfizer concluded that the use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose. The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision, and dizziness.
For more information on this recall, read the official statement.
Publix Super Markets Inc Recall Ground Beef Chunk Products Potentially Contaminated with E coli O26
Publix Super Markets Inc., a Lakeland, Fla., retail grocery store chain is voluntarily recalling an undetermined amount of ground beef products made from chuck that may be contaminated with Escherichia coli O26, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
On Aug. 16, 2018, FSIS was notified of an investigation of E. coli O26 illnesses. FSIS, the Centers for Disease Control and Prevention, and state public health and agriculture partners determined that raw ground chuck was the probable source of the reported illnesses. The epidemiological investigation identified 18 case-patients, predominantly from Florida, with illness onset dates ranging from July 5 to July 25, 2018. Traceback information indicated that case-patients consumed ground chuck products purchased at various Publix Super Markets that was supplied by a yet-to-be determined source. As this investigation further develops, FSIS will continue to work with the supermarket, suppliers and public health partners, and will provide updated information should it become available.
E coli O26, like the more common E coli O157:H7, is a serovar of Shiga toxin-producing E coli (STEC). People can become ill from STECs 2—8 days (average of 3–4 days) after exposure to the organism.
For a full list of recalled products, check out the recall alert.
Alcon Announces Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma
Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. The decision was based on 5-year data from COMPASS-XT long-term safety study.
In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.
This voluntary market withdrawal applies to all versions of the CyPass Micro-Stent. Alcon will be communicating directly with ophthalmic surgeons with recommendations for evaluating and managing those patients who have already received a CyPass Micro-Stent and instructions for returning unused devices.
For more information on this market withdrawal, check out the company announcement.
FDA Announces Recall of Montelukast tablets by Camber Pharmaceuticals due to Incorrect Drug in Bottles
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets — lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.
This tablet mix-up may pose a safety risk by taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels, and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.
This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).
For more information on this recall, check out the FDA's statement.