OTC Private Labeler RIJ Pharmaceutical Must 'Fully Remediate' Water System
Executive Summary
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.
You may also be interested in...
Altaire Recalled Millions Of OTC Eye Drops, Halted Production After Repeat GMP Problems Found
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. Warning submitted in March said falsifying data was found in making batch release decisions related to whether certain sterile ophthalmic drugs contained viable microorganisms.
US Health Market In 2019: Unfinished Business Leaves Lasting Impression
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.
Health And Wellness Recalls: More RIJ Pharmaceutical Private Label OTCs
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.