May 22, 2020
Audience: Consumer, Health Professional, Pharmacy
May 22, 2020 — Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to 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 bottles. See product images.
To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts.
|
Product |
NDC |
Lot # |
Exp. Date |
|---|---|---|---|
| NP Thyroid 30 mg | 42192-329-01 | M329A19-1 | 20-Dec |
| M329H18-1 | 20-Jul | ||
| M329J18-1 | 20-Aug | ||
| M329J18-2 | 20-Aug | ||
| M329J18-3 | 20-Aug | ||
| M329M18-2 | 20-Nov | ||
| NP Thyroid 60 mg | 42192-330-01 | M330J18-2A | 20-Aug |
| M330J18-3 | 20-Aug | ||
| NP Thyroid 90 mg | 42192-331-01 | M331G18-1 | 20-Jun |
| M331J18-1 | 20-Aug | ||
| M331J18-2 | 20-Aug | ||
| M331M18-1 | 20-Nov | ||
| M331M18-2 | 20-Nov |
Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product 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 Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
Related Post
26 Feb
Study Reveals Extent of Undiagnosed Cancer Cases Due to COVID-19 Pandemic
North of 134,000 disease cases went undiscovered in the U.S. during the initial 10 months of the Coronavirus pandemic, as per another College of Kentucky Markey Disease Center review. The report distributed in JAMA Oncology gives the principal assessments of.
Read More
26 Feb
Another COVID Toll: Over 134,000 Undiagnosed Cancers During Height of Pandemic
In excess of 134,000 diseases could have gone undiscovered during the initial 10 months of the Coronavirus pandemic, as per an investigation of public patterns in malignant growth rate. Yearly disease occurrence fell practically 30% shy of the normal rate from.
Read More
26 Feb
Top 10 Health Benefits of Eucalyptus
Eucalyptus is an evergreen tree local to Australia. Throughout the long term, eucalyptus leaves and oils have been consumed and made into prescription for different medical issue for people all over the planet. During the eighteenth and nineteenth hundreds of.
Read More
15 Feb
Migraine Causes, Symptoms, Treatments, And More
Headaches can strike whenever. They influence around 15% of Americans, and ladies are multiple times bound to get them than men. Elizabeth Ekpo and Marc Lenaerts, cerebral pain medication experts in UC Davis Wellbeing's Division of Nervous system science, make.
Read More