Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syring...

FDA Recall #D-0064-2024 — Class II — October 2, 2023

Recall #D-0064-2024 Date: October 2, 2023 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Pine Pharmaceuticals, LLC — Tonawanda, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

860 syringes

Distribution

Nationwide within the United States

Code Information

Lot #: 67808, Exp. Date 10/23/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated