Dairy Manufacturers Inc. Issues Voluntary Recall of Products Due to Non-Compliance with Requirements Under the 21 CFR 106.110 New Infant Formula Registration

Abstract

Firm Announcement

Dairy Producers Inc., of Prosper, TX – 5/24/24, is voluntarily recalling all lot codes for toddler formulation obtainable within the US: Crecelac Toddler 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose to the retail and wholesale stage. The merchandise have been present in non-compliance with the necessities of the FDA underneath part 21 CFR 106.110 New Toddler components registration.

Dairy Producers is conducting this voluntary recall as a result of the merchandise listed had been offered within the U.S. with out complying with the FDA’s toddler components laws. This was recognized after an FDA notification, as a result of the agency has not submitted the required premarket notification. Mother and father and caregivers ought to perceive that the merchandise haven’t been evaluated by FDA to find out whether or not they meet U.S. meals security and dietary requirements. No diseases have been reported to this point.

The merchandise are labeled as toddler components and are packaged in a cardboard and aluminum can of 12.4 oz. Merchandise had been offered solely within the state of Texas at retail stage. The recalled merchandise are:

Shoppers who’ve bought Crecelac Toddler 0-12, Farmalac 0-12 and Farmalac 0- 12 low lactose are urged to discontinue use of the recalled merchandise and return it to the place of buy for a full refund. There have been no identified studies of accidents or opposed reactions as a result of consumption of those merchandise. Anybody involved about an damage or sickness ought to contact a healthcare supplier.

Shoppers with questions could contact the corporate at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to five p.m. EST).

This recall is being made with the information of the Meals and Drug Administration.

We sincerely apologize for any inconvenience or concern this may occasionally trigger and guarantee our clients that we’re taking all crucial steps to make sure the protection, high quality, and compliance of our merchandise.