Recalls / Class I
Class IF-0502-2021
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
ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 & 5lb, UPC 6 49241 87832 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
- Type
- Food
- Affected lot / code info
- 2lb - All EXP DATES up to and including 10/2023 5lb - All EXP DATES up to and including 09/2021
- Quantity
- 2lbs - 315 jugs + 5lbs 378 jugs
Why it was recalled
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
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-0502-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.