Category Archives: microbial contamination

USA – Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Posted on August 29, 2018 by | Leave a comment

FDA bacillus

FOR IMMEDIATE RELEASE – Franklin Lakes, NJ, 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.

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.

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.

Living Well Remedies, LLC has already notified these 101 consumers and is arranging for refund or replacement.

Consumers with questions regarding this recall can contact Living Well Remedies, LLC by email at CustomerCare@LivingWellRemedies.com, or at 1-800-249-7705, M-F 9AM-3PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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Posted in Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology Blog, food recall, Food Safety, Food Testing, microbial contamination, Microbiology, Uncategorized

USA – FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products – Microbial Contamination

Posted on August 29, 2018 by | Leave a comment

FDA

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.

King Bio manufactures a range of products including those for children, adults and pets. Products that are part of the recall include Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief. The full list of products is listed on the King Bio websitedisclaimer icon.

Consumers and pets who use these products could have an increased risk of serious infection, that could require medical attention, due to the high levels of microbial contamination. An infection could be a life-threatening event for immunocompromised patients. Consumers and pet owners who have purchased these products should contact their health care professional if they have concerns or observe signs of an infection after use of these products.

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Posted in food contamination, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, microbial contamination, Microbiology, Uncategorized

USA -King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

Posted on August 23, 2018 by | Leave a comment

FDA

King Bio is voluntarily recalling the below products to the consumer level.

A small percentage of our products produced between 08/01/2017 and 04/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below.

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. King Bio has not received reports of injury or illness to date.

King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should discontinue use/distribution and contact King Bio at recall@kingbio.com to make arrangements to return product. These products were distributed Nationwide to distributors and retail stores August 2017 – July 2018.

Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail recall@kingbio.com, Monday – Thursday 830am – 330pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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Posted in FDA, Food Micro Blog, Food Microbiology, Food Microbiology Blog, microbial contamination, Microbiology, Uncategorized

USA -Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Posted on August 9, 2018 by | Leave a comment

FDA

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. THolly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

Risk Statement: Repetitive use of a nasal spray 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  immuno-compromised. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall.

The product is used as a nasal decongestant and is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton. 16,896 units were released with UPC code 50428432365.  The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is Lot # 173089J, EXP 09/19. The product can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health on top left. The IFC containing the bottle is also orange and contains the same wording.  Lot 173089J and EXP 09/19 is coded on the side panel of the carton. Product was distributed Nationwide to retail outlets.

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Posted in microbial contamination, Microbiology, Recall, Uncategorized