Lidocaine HCL 2% and Oxymetazoline HCl 0 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 Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounde…

Recall number

D-0064-2024

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

Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.