Product: Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
Reason for recall: 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.
Recall initiated: 20180119
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated