Drug & medication recalls Moderate risk

Hydromorphone HCl 0 recalled over sterility concerns

Recall date
August 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Family Pharmacy of Statesville recalls Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Recall number
D-0659-2022
FDA classification
Class II
Brand / firm
Family Pharmacy of Statesville
Sold / distributed
NC only

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

Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

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