Drug & medication recalls Moderate risk

10 mg/mL Rocuronium Bromide BD Syringe recalled over manufacturing violations

Recall date
July 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
PharMEDium Services, LLC recalls 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Recall number
D-1045-2018
FDA classification
Class II
Brand / firm
PharMEDium Services, LLC
Sold / distributed
Product was distributed throughout the United States

Why it was recalled

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

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

What was recalled

10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

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