FDA Recalls

Fluorescein Strip Recall

Sarah Nordberg's picture

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We got a notice yesterday that fluorescein strips manufactured by Vistamerica were recalled. This comes a week after there was a notice about BioGlo strips. Both seem to be made through “Wizcure Pharmaa” since they both state the manufacturer is, “voluntarily recalling Fluorescein item/lot due to the Wizsure Pharmaa recall due to the product manufactured was not in conformance with current good manufacturing practices.” We pulled back all of our stock but there are no alternatives that I know of. Is anyone else affected and do you have a plan you could share?

System-level FDA Recall Management

Bryan R Bailey's picture

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Greetings,

Does anybody have a system-level policy/process regarding management of recalls for pharmaceuticals, medical equipment/devices, etc they could share? I’m specifically interested in any policies/mechanisms that include requirements for individual facilities to report back to system leadership about recall impact and actions taken in response to a recall (e.g., quantity on hand, quantity unaccounted for, removal of product from stock completed, # of patients affected, level of patient harm, was patient notification necessary, patient notification completed).

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