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Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Sub potency

Company Name:
Acella Pharmaceuticals, LLC
Brand Name:

Brand Name(s)

Product Description:

Product Description

NP Thyroid (Thyroid Tablets, USP)


Company Announcement

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 Attachment A hereto. 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 [email protected] 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.

  • 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.

Attachment A

Table 1. List of 35 Recalled Commercial Lots (100-count Bottles)

#Product DescriptionNDC NumberLot NumberExp. DateDistribution Dates
1NP Thyroid® 15mg Tablets42192-327-01M327D20-13/31/202208/11/2020 – 10/06/2020
2NP Thyroid® 15mg Tablets42192-327-01M327D20-33/31/202207/20/2020 – 09/29/2020
3NP Thyroid® 15mg Tablets42192-327-01M327H19-3A7/31/202106/23/2020 – 07/08/2020
4NP Thyroid® 15mg Tablets42192-327-01M327L19-14/30/202103/04/2020 – 04/30/2020
5NP Thyroid® 120mg Tablets42192-328-01M328H19-2B8/31/202109/16/2020 – 09/24/2020
6NP Thyroid® 120mg Tablets42192-328-01M328J19-118/31/202104/15/2020 – 06/09/2020
7NP Thyroid® 120mg Tablets42192-328-01M328J19-2A8/31/202107/28/2020 – 08/07/2020
8NP Thyroid® 120mg Tablets42192-328-01M328J19-3A8/31/202108/07/2020 – 09/02/2020
9NP Thyroid® 120mg Tablets42192-328-01M328J19-4A8/31/202108/31/2020 – 02/09/2021
10NP Thyroid® 120mg Tablets42192-328-01M328J19-5A8/31/202109/04/2020 – 11/18/2020
11NP Thyroid® 120mg Tablets42192-328-01M328J19-6A8/31/202109/14/2020 – 10/16/2020
12NP Thyroid® 120mg Tablets42192-328-01M328J19-7A8/31/202109/29/2020 – 10/14/2020
13NP Thyroid® 120mg Tablets42192-328-01M328K19-29/30/202104/02/2020 – 10/02/2020
14NP Thyroid® 120mg Tablets42192-328-01M328K19-4A9/30/202109/25/2020 – 11/25/2020
15NP Thyroid® 30mg Tablets42192-329-01M329D20-13/31/202205/12/2020 – 02/02/2021
16NP Thyroid® 30mg Tablets42192-329-01M329D20-23/31/202206/22/2020 – 09/08/2020
17NP Thyroid® 30mg Tablets42192-329-01M329D20-33/31/202207/13/2020 – 09/28/2020
18NP Thyroid® 60mg Tablets42192-330-01M330D20-13/31/202208/11/2020 – 03/16/2021
19NP Thyroid® 60mg Tablets42192-330-01M330D20-23/31/202209/25/2020 – 10/12/2020
20NP Thyroid® 60mg Tablets42192-330-01M330J19-2A8/31/202106/16/2020 – 06/16/2020
21NP Thyroid® 60mg Tablets42192-330-01M330J19-4A8/31/202107/28/2020 – 08/19/2020
22NP Thyroid® 60mg Tablets42192-330-01M330J19-5A8/31/202106/18/2020 – 06/24/2020
23NP Thyroid® 60mg Tablets42192-330-01M330J19-6A8/31/202107/01/2020 – 07/15/2020
24NP Thyroid® 60mg Tablets42192-330-01M330J19-7A8/31/202106/10/2020 – 06/30/2020
25NP Thyroid® 60mg Tablets42192-330-01M330J19-9A8/31/202105/29/2020 – 06/04/2020
26NP Thyroid® 60mg Tablets42192-330-01M330K19-109/30/202103/31/2020 – 05/07/2020
27NP Thyroid® 60mg Tablets42192-330-01M330K19-1A9/30/202108/19/2020 – 08/26/2020
28NP Thyroid® 60mg Tablets42192-330-01M330K19-99/30/202105/04/2020 – 08/26/2020
29NP Thyroid® 90mg Tablets42192-331-01M331J19-10A8/31/202108/19/2020 – 08/27/2020
30NP Thyroid® 90mg Tablets42192-331-01M331J19-118/31/202104/03/2020 – 04/27/2020
31NP Thyroid® 90mg Tablets42192-331-01M331J19-2A8/31/202107/28/2020 – 08/05/2020
32NP Thyroid® 90mg Tablets42192-331-01M331J19-6A8/31/202109/29/2020 – 10/08/2020
33NP Thyroid® 90mg Tablets42192-331-01M331K19-19/30/202104/27/2020 – 06/10/2020
34NP Thyroid® 90mg Tablets42192-331-01M331K19-29/30/202104/23/2020 – 07/29/2020
35NP Thyroid® 90mg Tablets42192-331-01M331K19-69/30/202106/11/2020 – 07/08/2020

Table 2. List of 3 Recalled Sample Lots (7-count Bottles)

#Product DescriptionNDC NumberLot NumberExp. DateDistribution Dates
1NP Thyroid® 15mg Tablets42192-327-07M327D20-13/31/202208/04/2020 – 03/19/2021
2NP Thyroid® 30mg Tablets42192-329-07M329D20-23/31/202208/14/2020 – 03/19/2021
3NP Thyroid® 120mg Tablets42192-328-07M328J19-9B8/31/202101/25/2021 – 03/19/2021

Company Contact Information


Product Photos

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Author: FDA

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