It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Reason for recall: It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages. Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA and the countries of Canada, P.R. China and Thailand. Quantity: 465 boxes x 500 units per box = 232,500 units Lot/code info: Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
00609576330322
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.