Class IF-0511-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

HI-TECH PHARMACEUTICALS PRECISION PROTEIN COOKIES & CREAM NET WT 2lbs (907g) container UPC 8 11836 02341 1 & 5lbs. (2.2kg) UPC 8 11836 02349 7 manufactured by Hi-Tech Pharmaceuticals, 6015-B Unity Dr. Norcross, GA

Type: Food
Affected lot / code info: 2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 10/2023
Quantity: 2lbs - 2,446 jugs + 5lb - 757 jugs

Why it was recalled

During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".

Recalling firm

Firm: Hi Tech Pharmaceuticals
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 6015 Unity Dr Ste B, N/A, Norcross, Georgia 30071-3575

Distribution

Distribution pattern: Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY.

Timeline

Recall initiated: 2021-04-03
FDA classified: 2021-05-18
Posted by FDA: 2021-05-26
Status: Ongoing

Source: openFDA Food Enforcement endpoint. Recall record F-0511-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.