'Re­call ready': FDA urges com­pa­nies to com­ply with drug re­call guid­ance

The FDA has fi­nal­ized guid­ance to help com­pa­nies quick­ly re­call prod­ucts and take the nec­es­sary steps be­fore a prod­uct reach­es the re­call stage, as part of work pull vi­ola­tive prod­ucts and keep them out of the hands of con­sumers.

Ini­ti­a­tion of Vol­un­tary Re­calls of­fers guid­ance for com­pa­nies to de­vel­op pro­ce­dures in­clud­ing train­ing, plan­ning and record-keep­ing to re­duce the time a dan­ger­ous prod­uct is on the mar­ket and lim­it the risk of ex­po­sure. The FDA can re­call con­trolled sub­stances, bi­o­log­i­cal prod­ucts, hu­man cells, tis­sues and cel­lu­lar and tis­sue-based prod­ucts, as well as med­ical de­vices and food.

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