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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