Warning letter · FDA Warning Letters, Historical Archive

Hi Tech Pharmaceuticals: FDA Warning Letter 560788 (Apr 10, 2019)

Agency action: Apr 10, 2019Record ID: fda_warning_-169bdca36b38a6dc
View official source ↗

What happened

Original notice title

Hi Tech Pharmaceuticals MARCS-CMS 560788, April 10, 2019

From the archived source record

Dietary Supplement/Adulterated. Issuing office: Center for Food Safety and Applied Nutrition.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
d65ec9223f08

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Ultimate Orange; HydroxyElite; Lipodrene Elite; labels declares 2-Aminoisoheptane HCl as a dietary ingredient
Company
Hi Tech Pharmaceuticals
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.