Here are three things to know.
- Sonar Products and its distributor, Miami-based Stratus Pharmaceuticals, respectively manufactured and distributed various dermatological products not approved by the FDA, including ointments, creams and washes. The companies “routinely shipped unapproved, improperly labeled and substandard or contaminated drugs in interstate commerce,” the FDA said Thursday in a news release.
- In 2015, officials confiscated more than $16 million worth of unapproved prescription drug products from the companies. The FDA has also identified numerous manufacturing violations involving the companies since 2014 and discovered Stratus failed to appropriately address more than 1,300 consumer complaints, according to the news release.
- Under a consent decree, Sonar must stop all operations until it hires a manufacturing compliance expert, addresses all violations and earns written permission from the FDA to continue operations. Stratus is forbidden from distributing unapproved products until it receives all necessary FDA approvals, according to the news release.
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