Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration
- Company Announcement Date:
- August 09, 2018
- FDA Publish Date:
- August 10, 2018
- Product Type:
- Reason for Announcement:
- Company Name:
- Westminster Pharmaceuticals, LLC
- Brand Name:
Brand Name(s)Westminster Pharmaceuticals, LLC
- Product Description:
Product DescriptionLevothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg
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.
|69367-159-04||Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct||15918VP03||2/29/2020|
Levothyroxine and Liothyronine (Thyroid Tablets, USP) 30mg X 100ct
|69367-156-04||Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct||15618011||3/31/2020|
|69367-157-04||Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct||15717VP-01||7/31/2019|
|69367-158-04||Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct||15817VP-01||9/30/2019|
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 email@example.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
Company Contact Information
- Jonathan H. Olive