Westminster Pharmaceuticals, LLC. Nationwide Recall of Levothyroxine and Liothyronine

PUBLISHED: Aug 13, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy, Rural Health Clinics

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. 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. The product the NDC’s, Product Description, Lot numbers and Expiration dates are listed in the recall notice, link below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.

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 the recalled products 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

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

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