Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sterilized water for injections BP Recalled by Flawless Beauty LLC Due to Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC...

Date: January 19, 2018
Company: Flawless Beauty LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Flawless Beauty LLC directly.

Affected Products

Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India

Quantity: N/A

Why Was This Recalled?

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Flawless Beauty LLC

Flawless Beauty LLC has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report