Enforcement Report - Week of May 15, 2024
Enforcement Report - Week of December 7, 2022
Enforcement Report - Week of November 30, 2022
Enforcement Report - Week of June 2, 2021
Last May, Acella Pharmaceuticals pulled 13 lots of its prescription hypothyroidism med NP Thyroid in the U.S. after testing revealed an excess of one of the drug's main ingredients. Now, the company is facing the opposite problem.
ATLANTA, April 29, 2021 /PRNewswire/ -- 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).
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates
Calvin Scott, Acella Pharmaceuticals, Soluciones Cosmeticas and TAKA USA warning letters highlight issues with quality units, process control and specifications.
Acella Pharmaceuticals Receives FDA Warning Letter
The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.