Acella NP Thyroid (Thyroid Tablets, USP) - recalled due to sub potency, USA

2 years ago •source www.fda.gov

Recall notice

United States

Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: NP Thyroid (Thyroid Tablets, USP)
Reason of the recall: Sub potency
FDA Recall date: April 30, 2021
Recall details: Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.

To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below. To best identify the product, the NDC’s, Product Description, Lot Numbers, and Expiration Dates are listed on the link below.

These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #us #sub

Recent Interesting Reports

Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More
CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NM, NC, NY, NJ, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, and WY through website. The recalled products were also sold via the below websites via courier direct delivery and mail order. Etsy, amazon, eva-nutrition, tejocotemexican, niwali, scienceofalpha. The recalling firm has not received any reported of illness.

Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov
See Less

#recall #us

C
I received a package from Heather's Motty from Heathers Motty 2207 Summit Avenue, Union City, NJ. The return address is associated with YUANHENG AAA, LLC which appears to be a Hong Kong based trading and fulfilment company. The company also has an affiliate in Flushing, NY I … See More
have ordered products from China based companies, but not recently, and did not order these items.
See Less

#unorderedpackage #delivery #2207summitavenue #unioncity #newjersey #us

Create a Report

Please provide report title
Please provide location
Please provide details

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone
Please provide email or phone

Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by

Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery
Last 30 days