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Pharmaceuticals / Inspections and Audits

Imprimis Hit With Warning Letter Amidst Lawsuit

Jan. 23, 2018

The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created a public health concern.

Imprimis is currently embroiled in a false advertising lawsuit spearheaded by Allergan, manufacturer of the dry-eye drug Restasis. Allergan claimed the San Diego, California-based company made four misleading statements and unlawfully manufactured drugs under the guise of compounding.

The FDA warning letter targeted Imprimis for misbranding its Dropless, LessDrops, SimpleDrops and Klarity C-Drops products through promotional materials, stating that the violations created public health concerns regarding their safety and effectiveness.

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