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 out there 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 below part 21 CFR 106.110 New Toddler system registration.

Dairy Producers is conducting this voluntary recall as a result of the merchandise listed had been bought within the U.S. with out complying with the FDA’s toddler system laws. This was recognized after an FDA notification, as a result of the agency has not submitted the required premarket notification. Dad and mom 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 sicknesses have been reported thus far.

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

Customers 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 hostile reactions on account of consumption of those merchandise. Anybody involved about an damage or sickness ought to contact a healthcare supplier.

Customers 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 will trigger and guarantee our prospects that we’re taking all vital steps to make sure the protection, high quality, and compliance of our merchandise.