OTC Private Labeler RIJ Pharmaceutical Must 'Fully Remediate' Water System
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.
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Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
Geritrex recalls nearly 40,000 bottles of cough/cold and stool softener products mae by RIJ. Latest update to FDA's recalls database also includes cannabidiol-containing OTC lidocaine topicals marketed by Pharma-Natural Inc. and Herbal Doctor Remedies products the agency warned about in 2017.
FDA warns King Bio, three other homeopathic product marketers. In addition to GMP deficiencies, "we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer,” says FDA Commissioner Gottlieb.