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

Recall Number: D-0332-2018

Firm: Flawless Beauty LLC

Classification: Class II

Status: Terminated

Report Date: 20180214

Initiation Date: 20180119

Termination Date: 20180913

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.

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