BlendHouse LLC. Reading, PA. EIR issued 02/17/2023

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.

CGMP/Finished Pharmaceuticals/Adulterated

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)