Hi-Tech Pharmaceuticals Recalls Precision Protein Cookies & Cream for Gluten Mislabeling
Hi-Tech Pharmaceuticals is recalling Precision Protein Cookies & Cream because it contains wheat but is labeled as "Gluten Free".
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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"."
Plain-English summary
Hi-Tech Pharmaceuticals is recalling Precision Protein Cookies & Cream in 2lb and 5lb containers. The recall was initiated after an FDA inspection revealed that the product contains wheat, despite the label stating it is "Gluten Free".
The affected products are identified by specific UPC codes and expiration dates. The 2lb containers (UPC 8 11836 02341 1) have expiration dates up to and including 12/2022. The 5lb containers (UPC 8 11836 02349 7) have expiration dates up to and including 10/2023. The product was distributed to numerous states across the United States, including 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, and WY.
Consumers with this product should stop using it and contact the manufacturer for further instructions. Individuals with celiac disease or gluten sensitivity should be particularly cautious, as the presence of wheat contradicts the "Gluten Free" claim on the packaging.
The recalled product
- 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
- Manufacturer
- Hi Tech Pharmaceuticals
- Category
- Food — Protein Supplements
Distribution
Part of a larger recall action
This product is one of 14 recalled by Hi Tech Pharmaceuticals under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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