Drug & medication recalls Moderate risk

Vancomycin 1 MG/ Solution for Intraocular Injection 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 Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharma…
Recall number
D-0051-2024
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

Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

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