FDA Enforcement and Recall Report Week of July 18
Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.
This week continues the slow roll out of recalls. The biggest burst coming from the continued E. Coli concern with General Mills. Three of the 8 recalls posted related to the General Mills O121 issue that started about two weeks ago. This latest round captured companies using the flour in their own products. An additional three recalls related to undeclared allergens. A final two medical recalls rounded out the list for the week.
Warning letters are also lite with only two new postings. Both are for illegal drug residue in meat production animals. Although the USDA regulates the production of those animals, the FDA sets the thresholds on animal feed and medicated feeds. Both letters raise issues under this authority.
Recalls Week of July 18
|07/15/2016||Rugby||Diocto Liquid, docusate sodium solution||Burkholderia cepacia contamination||PharmaTech LLC|
|07/15/2016||Tippin’s||Key Lime Pie||Undeclared peanut||Tippin’s Gourmet Pies, LLC|
|07/14/2016||Poppers||Mozzarella Cheese Sticks||Undeclared egg||Monogram Appetizers, LLC|
|07/13/2016||Marie Callender’s||Biscuit Mix||E. coli O121||International Commissary Corporation|
|07/12/2016||Golden Dipt||Jalapeno Breader||E. coli O121||Kerry Inc.|
|07/12/2016||Snack Factory||Pretzel Crisps||Undeclared milk||Baptista’s Bakery, Inc.|
|07/11/2016||Betty Crocker||Cake Mix||E. coli O121||General Mills|
|07/11/2016||Alere INRatio, Alere INRatio2||Monitoring System||Patients with certain medical conditions should not be tested with the system||Alere|
Warning Letters Week of July 18
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|June 30, 2016||Morwai Dairy||Denver District Office||Illegal Drug Residue||Not Issued *|
|June 28, 2016||Robin Martin||Detroit District Office||Illegal Drug Residue||Not Issued *|
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.