Drug & medication recalls Moderate risk

Calcium chloride Solution for Intravenous 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 Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals…
Recall number
D-0061-2024
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

Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

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