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OTC Private Labeler RIJ Pharmaceutical Must 'Fully Remediate' Water System

 
• By Eileen Francis

FDA asks RIJ Pharmaceutical, which recalled a dozen products last year, to provide plans for developing a solid water system design and mixing process. It warns private label manufacturer about contaminated, "‘super-potency" OTC drugs that resulted from GMP violations.

Warning Rubber Stamp

The US Food and Drug Administration's inspection of RIJ Pharmaceutical LLC in 2018 a month before the private label manufacturer recalled OTC cough and cold products due to contaminated water launched a process that could lead to the firm closing its facility for remediation.

An FDA warning letter published April 16 says RIJ has not shown its water system can consistently produce water suitable...

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