FDA recall F-0781-2023

Product

PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA SOY FLR 200/70 STD 50LB BG, PROLIA SOY FLR 200/70 NT 2000LB TT, PROLIA SOY FLR 200/70+15 STD 50LB BG, PROLIA SOY FLR 90 STD 2000LB TT, PROLIA SOY FLR 200/70 NT BLK, PROLIA SOY FLR 200/20 XTRA 50LB BG, PROLIA SOY FLR 100/20 STD BB, PROLIA SOY FLR 200/70 STD 50LB BG NGM, PROLIA SOY FLR 200/20 NT 2000LB TT, PROLIA SOY FLR 200/70 2000LB TT NGM; distributed in bulk, bulk bag, and 50 pound paper bags.

Reason for recall

Products with a gluten free claim may contain gluten levels above 20 ppm.

Distribution

Nationwide United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and United Kingdom

Key facts

Status

Terminated

Initiation date

2023-03-30

Report date

2023-05-10

Termination date

2023-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayzata, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0781-2023