Children’s Medicine Recall

Recall

The FDA has recently released a statement regarding more than 30 King Bio medicines for children and infants. A “small percentage” of the medicines tested positive for microbial contamination. 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 2018.1

What is a Microbial Contamination?

Microbial contamination is the unintended introduction of bacteria into a controlled area (petri dish, stock media, work station). 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.

What Products are Recalled?

You can find a list of the products affected on the FDA’s website.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742

 

Source:

  1. https://www.fda.gov/Safety/Recalls/ucm617945.htm

Hypothyroidism Medication Recall

Recall

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine. The FDA encourages patients and health care professionals to report any adverse reaction to the MedWatch program.

Why are these medications being recalled?

These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to a 2017 inspection which discovered deficiencies with Current Good Manufacturing Practices (cGMP). While there is risk involved in taking this product, to date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

What products are recalled?

You can find a detailed list of the products, lot numbers and expirations dates listed on the FDA’s website.

Next steps you should take

  • Because Levothyroxine and Liothyronine is used to treat serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.
  • Patients who are taking Levothyroxine or Liothyronine should contact the pharmacy that dispensed their medication to determine if their prescription is affected.   If your medication is one of the affected products the pharmacy can work with your physician to obtain a new prescription if necessary.

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

 

Source: https://www.fda.gov/Safety/Recalls/ucm616601.htm

 

Valsartan Recall

Recall

The FDA has recently released a voluntary recall of several drug products containing the active ingredient valsartan. These medications are primarily used to treat high blood pressure and heart failure. The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

Why is it being recalled?

The FDA identified a cancer-causing impurity within the recalled products based on laboratory test results. They believe the impurity is a result of the way the active substance was manufactured. Due to this, not all products containing valsartan are being recalled.

What products are recalled?

Medicine Company
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.

Next steps you should take

  • Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

 

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm