Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits

One Frozen, LLC of Rochester, NY, is voluntarily recalling certain lots of Good & Gather™ Southwest-Style Burrito Bowl Blend (frozen, 12oz bags) because the product may contain shrimp (crustacean shellfish) that was not declared on the ingredient label of the product. People who have an allergy or

Withdrawn and Expired Guidances | Drugs

Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.

The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.

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.

CGMP/Finished Pharmaceuticals/Adulterated