Drug recall

Cornea

FDA recall event 89783 · Class II · Banco de Ojos del Leonismo Puertorrique?o, Inc.

Key facts

Event ID 89783
Recall numbers B-0315-2022
Recalling firm Banco de Ojos del Leonismo Puertorrique?o, Inc.
Product type Biologics
Products Cornea
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Cornea, recovered from a donor in which donor suitability was not adequately determined, was distributed.
Initiation date Feb 8, 2022
Report date Apr 13, 2022
Termination date Apr 7, 2022
City San Juan
State PR
Country United States
FEI number 3001238469

At a glance

  • 1–9 Products in this recall
  • 1–9 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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