Endophth Kit recalled over sterility concerns

Recall date

October 2, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pine Pharmaceuticals, LLC recalls Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 River…

Recall number

D-0052-2024

FDA classification

Class II

Brand / firm

Pine Pharmaceuticals, LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.