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

FDA Extends EpiPen Expiration Dates

EpiPen

The good news continues for those who rely on EpiPens! The FDA has extended the expiration date of some EpiPens due to shortages. As the school year begins the demand for this life-saving drug has continued to rise. After manufacturing delays and supply disruptions, pharmacies have been struggling to keep EpiPens in stock.

How is the Expiration Date Changing?

The FDA has received “stability data” from Pfizer, a manufacturer of EpiPens, and conducted its own review to conclude the devices are effective beyond the expiration dates set by the manufacturers. This expiration date extension will only apply to specific lots of EpiPen that are expired or close to expiring. Specific batches of 0.3 milligram products manufactured by Mylan may be used for four months beyond their expiration dates. If you have any concerns regarding the usability of your EpiPen, contact your dispensing pharmacy.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742

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

 

Limit the Tylenol

Many prescription pain medications are combination products that contain varying amounts of Tylenol, or acetaminophen.  In the past, the Food and Drug Administration (FDA) has not placed limits on the amount of Tylenol that is included in these combo products.  That is changing as the FDA is asking manufacturers of these medications to limit the amount of Tylenol per pill to 325mg.

Excessive amounts of Tylenol can lead to serious liver damage.  If you are taking a prescription pain medication that contains Tylenol, it is important to avoid the use of over the counter products that contain acetaminophen (the same active ingredient as Tylenol).  Acetaminophen is available in a variety of over the counter remedies, including numerous cough and cold products.

Look and Ask!  Look at the active ingredient listing on all over the counter products and ask your pharmacist if you have any questions.