FDA recall D-0056-2024

Pine Pharmaceuticals, LLC · Class II · drug

Product

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

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2023-10-02
Report date
2023-10-25
Termination date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2024