Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mc...

FDA Recall #D-0056-2024 — Class II — October 2, 2023

Recall #D-0056-2024 Date: October 2, 2023 Classification: Class II Status: Terminated

Product Description

Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, 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

2484 syringes

Distribution

Nationwide within the United States

Code Information

Lot #: 67480, Exp. Date 10/9/2023; 68640,Exp. Date 12/3/2023; 68769, Exp. Date 12/9/2023; 68760, Exp. Date 12/10/2023; 68925, Exp. Date 12/16/2023;70119, Exp. Date 1/20/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated