Drug recall

Blood and Blood Products for Reprocessing

FDA recall event 75546 · Class II, Class III · American National Red Cross, Penn Jersey Region

Key facts

Event ID 75546
Recall numbers B-0191-2017, B-0192-2017
Recalling firm American National Red Cross, Penn Jersey Region
Product type Biologics
Products Blood and Blood Products for Reprocessing, Red Blood Cells, Leukocytes Reduced
Classification Class II, Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Initiation date Jul 21, 2016
Report date Dec 14, 2016
Termination date Dec 2, 2016
City Philadelphia
State PA
Country United States
FEI number 2573021

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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