Drug & medication recalls Moderate risk

HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16 recalled over sterility concerns

Recall date
December 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Pharmacy Innovations recalls HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th…
Recall number
D-0214-2023
FDA classification
Class II
Brand / firm
Pharmacy Innovations
Sold / distributed
Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

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