Wellements, LLC recalled two lots of Organic Iron Drops as they may contain an undeclared milk allergen, according to a statement published by the U.S. Food & Drug Administration.
The recall was initiated after Wellements was informed that one of the raw material ingredients used in the products was mistakenly blended with lactose, a milk constituent that contained milk allergen, by its manufacturer before supplying for the production of Wellements finished product. The packaging also did not reveal the presence of a milk allergen.
The recall involves 1oz/30ml bottle of Iron Drops liquid Dietary Supplement and the sample version being Iron Drops Sample liquid Dietary Supplement. These Iron Drops are indicated for use in Infants 4 months to Children 3 years of age.
The Iron Drops were distributed across the U.S. through select retail stores, Amazon.com and Wellements.com between May 1, 2019 and July 22, 2020, with best before dates of October 2020 and January 2021. They were sold in a 1oz glass amber bottle and packaged in an individual product carton that includes a 1ml oral syringe dispenser.
The recalled Iron Drops Sample were distributed across the U.S. through promotional giveaways in select consumer purchases and select partners between May 1, 2019 and July 22, 2020, with best before date of October 2020. They were sold in a 1oz glass amber bottle filled to 2ml and packaged in an individual “SAMPLE- NOT FOR RESALE” product carton that includes a 1ml oral syringe dispenser.
The Scottsdale, Arizona-based company said consumption of the recalled Iron Drops by people allergic or having severe sensitivity to milk allergens could lead to serious risk of allergic reactions.
The company confirmed that there has been one allergic reaction reported to date involving the Iron Drops.
Wellements urged consumers who have purchased the recalled products to return it to the place of purchase or contact them directly for a full refund. Those who received the promotional samples are urged to contact Wellements and return it.
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