Tuesday, August 21, 2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

fda-logo.jpg
 
While I try to keep most info here dealing with tech topics or advancements, every once in a while I come across some healthcare info that, while isn’t strictly tech, for sure needs to be disseminated to all of you.  So, for today I think it’s important to get the word out on a FDA recall on dosages of a common thyroid medication.
 
Here is the report from the FDA website:
 

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

Levothyroxine and Liothyronine (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. Thyroid tablets contain both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated as replacement or supplemental therapy in patients with hypothyroidism. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. Thyroid is not associated with serious adverse reactions and does not have a known tumorigenic potential.

Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.

The products subject to recall are packed in 100-count bottles. To best identify the product the NDC’s, Product Description, Lot numbers and Expiration dates are listed below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.

NDC
Product
Lot
Expiration
69367-159-04
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct
15918VP03
2/29/2020
15918VP02
2/29/2020
15918VP01
2/29/2020
15918007
3/31/2020
15918006
3/31/2020
15918005
2/29/2020
15918004
12/31/2019
15918003
12/31/2019
15918002
12/31/2019
15918001
12/31/2019
15917VP03
10/31/2019
15917VP02
10/31/2019
15917VP01
10/31/2019
69367-155-04
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 30mg X 100ct
15517VP01
8/31/2019
15517VP02
8/31/2019
15517VP03
8/31/2019
15518001
12/31/2019
15518002
3/31/2020
69367-156-04
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct
15618011
3/31/2020
15618009
2/29/2020
15618008
2/29/2020
15618004
12/31/2019
15618002
12/31/2019
15617VP06
11/30/2019
15617VP05
11/30/2019
15617VP04
12/31/2019
15617VP03
7/31/2019
15617VP01
7/31/2019
15617VP-02
7/31/2019
69367-157-04
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct
15717VP-01
7/31/2019
15717VP-02
7/31/2019
15717VP-03
7/31/2019
15718004
3/31/2020
15717002
12/31/2019
69367-158-04
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct
15817VP-01
9/30/2019
15817VP-02
9/30/2019
15817VP-03
9/30/2019
15818001
3/31/2020
Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their sub-wholesale accounts of this product recall and make arrangements for impacted product to be returned to Westminster. Instructions for returning recalled products are given in the Recall Notice Letter and Recall Response Form. Consumers that have these products which are being recalled should not discontinue use before contacting their physician for further guidance.

Customers and patients with medical-related questions, information about an adverse event or other questions about the Westminster’s product’s being recalled should contact Westminster’s Regulatory Affairs department by phone at: 888-354-9939

Live calls are received Monday-Friday, 9:00AM - 5:00PM EST with voicemail available 24 hours/day, 7 days/week or email recalls@wprx.com.
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: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

Post a Comment