Drug & medication recalls Moderate risk

Foscarnet Sodium 2 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 Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounde…
Recall number
D-0065-2024
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

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.

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