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Thyroid Tablets Recalled
Manufacturing errors have prompted Westminster Pharmaceuticals to recall multiple lots of levothyroxine and liothyronine thyroid tablets, according to the August 29, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The “product was manufactured using an adulterated active pharmaceutical ingredient,” the FDA reported. “Additionally, lack of process controls and good manufacturing practices resulted in [the] finished product failing [to meet] content uniformity specifications, which can result in a product having a strength that is more or less than is labeled.”
The recall affects the following products, which were distributed in the United States and Puerto Rico:
- levothyroxine and liothyronine thyroid tablets, USP, 1 grain (60 mg), 100-count bottles (NDC 69367-156-04), from lots 15617VP03, 15617VP01, and 15617VP-02 (Exp. 7/31/19), 15617VP06 and 15617VP05 (Exp. 11/30/19), 15617VP04, 15618004, and 15618002 (Exp. 12/31/19), 15618009 and 15618008 (Exp. 2/29/20), and 15618011 (Exp. 3/31/20);
- levothyroxine and liothyronine thyroid tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles (NDC 69367-157-04), from lots 15717VP-01, 15717VP-02, and 15717VP-03 (Exp. 7/31/19), 15717002 (Exp. 12/31/19), and 15718004 (Exp. 3/31/20);
- levothyroxine and liothyronine thyroid tablets, USP, 1/2 grain (30 mg), 100-count bottles (NDC 69367-155-04), from lots 15517VP01, 15517VP02, and 15517VP03 (Exp. 8/31/19), 15518001 (Exp. 12/31/19), and 15518002 (Exp. 3/31/20);
- levothyroxine and liothyronine thyroid tablets, USP, 1/4 grain (15 mg), 100-count bottles (NDC 69367-159-04), from lots 15917VP03, 15917VP02, and 15917VP01 (Exp. 10/31/19), 15918004, 15918003, 15918002, and 15918001 (Exp. 12/31/19), 15918VP03, 15918VP02, 15918VP01, and 15918005 (Exp. 2/29/20), and 15918007 and 15918006 (Exp. 3/31/20); and
- levothyroxine and liothyronine thyroid tablets, USP, 2 grain (120 mg), 100-count bottles (NDC 69367-158-04), from lots 15817VP-01, 15817VP-02, and 15817VP-03 (Exp. 9/30/19), and 15818001 (Exp. 3/31/20).
Westminster Pharmaceuticals voluntarily initiated the recall August 3, 2018. At the time of its August 29, 2018, recall report, the FDA had not yet classified the recall.
Available with a prescription, levothyroxine and liothyronine thyroid tablets are used to treat patients with hypothyroidism.
—Jolynn Tumolo
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