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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-67/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135698

FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Eclipse Aesthetics, LLC.** Farmers Branch, TX (3/28). Inspected 8/5-13/15\. Adulterated, misbranded: The firm does not have an approved PMA or IDE application. Also, the firm did not notify the agency of its intent to introduce the device into commercial distribution. The Eclipse MicroPen Elite appears to consist of a stamp of needles that is controlled by a motor in order to make multiple controlled-depth penetrations perpendicularly into the skin while the operator moves the Eclipse MicroPen Elite across the skin surface. FDA has safety concerns regarding the potential for the needles to damage vessels and nerves because the safe ranges for needle lengths, penetration depths, and speeds of the device are unknown. The Eclipse MicroPen Elite exceeds the limitations of exemptions from section 510(k), etc. (Eclipse MicroPen Elite); FDCA 515(a), 502(o)  

[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500631.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500631.htm?ref=fdaweb.com)

**Economax, LLC** Flushing, NY (5/6). Unapproved new drug, misbranded: FDA confirmed through laboratory analysis that a sample of the firm’s “Super Power Khan” contains the undeclared active pharmaceutical ingredients sildenafil and hydroxyhomosildenafil, which cause this product to be misbranded. These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. The labeling for this drug fails to bear adequate directions for use, etc. (Super Power Khan); FDCA 505(a), 502(f)(1)&(2), 502(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm499839.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm499839.htm?ref=fdaweb.com)

**Lincare Holdings, Inc. dba United Medical Home Infusion**, Clearwater, FL (4/25). Inspected 6/1-12/15\. Adulterated: Investigators observed five insect-like pests, including a live worm-like pest, in the ISO 8 area adjacent to the clean areas. Also, two technicians were cleaning the ISO 5 hoods wearing non-sterile gloves and touching a liner of a garbage bin and placing their hands back into the ISO 5 areas without sanitizing or changing gloves. The investigators found that the firm had failing differential pressures between the ISO 7 area and the ISO 8 Ante-room, which creates the risk of dirtier air mixing with cleaner air within the aseptic processing areas, etc. (drug products); FDCA 301(k), 501(a)(2)(A)  

[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500608.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500608.htm?ref=fdaweb.com)  
  
**Reviva Labs, Inc.** Haddonfield, NJ (5/10). Inspected 10/23/15-11/18/15\. Unapproved new drugs: The claims on the firm’s product labels and Web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body. For example, the Web site for Nasolabial Fold Multi-Peptide Cream makes the claim: “Special new peptides and additional ingredients can help increase the volume of fatty tissue.” The product label for Skin Lightener For Day Fade Cream claims: “Results for lightening age spots or discoloration like never before…” (Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, etc.); FDCA 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500684.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500684.htm?ref=fdaweb.com)