Recalls / Class I
Class IF-0498-2021
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 BANANA CREAM PIE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89846 7 & 5LB, UPC 6 49241 87829 2 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 07/2021 5lb - All EXP DATES up to and including 03/2023
- Quantity
- 2lbs - 992 jugs + 5lbs - 327 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-0498-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings.