FDA recall D-0065-2024

Product

Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip 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-0065-2024