Federal judge orders Keystone Laboratories to cease sales of over-the-counter products due to violations

Federal judge orders Keystone Laboratories to cease sales of over-the-counter products due to violations

A federal judge has ordered Memphis-based Keystone Laboratories to cease the sale of a handful of its over-the-counter products due to alleged federal violations, according to the Memphis Business Journal.

U.S. District Judge John Fowkles Jr has ordered a permanent injunction against the company, which has hair and skin care brands Ultra Glow, Better Braids, Better Locks and Long Aid, following a complaint by U.S. Department of Justice on behalf of the Food and Drug Administration (FDA).

According to a news release, the complaint stated that Keystone Laboratories, which sells its products in Walmart, did not adequately investigate sources of contamination found in some of its products and failed to ensure its drug products met their specifications before releasing them to consumers.

The FDA also accused the company of failing to adhere to label requirements for OTC drug products and that Keystone misbranded.

The decree follows previous warnings by the FDA that it was putting at consumers at risk by manufacturing OTC drug products in violation of ‘current good manufacturing practice (CGMP) requirements’ and that it failed to provide adequate instructions for use on packages.

Keystone must now cease sale of its OTC drug products until it complies with the Federal Food, Drug and Cosmetic Act (FD&C).

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