Sterility Concerns Spark Altaire's CVS, Walmart, Walgreens Eye Drop Recalls
Executive SummaryAltaire "is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility," firm says in its recall announcements.
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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.
Contract manufacturer Ecometics may have distributed adulterated OTC drugs due to inadequate removal of residues from manufacturing equipment it also uses to make insect repellent, FDA says; and Altaire Pharmaceuticals expands its recall of OTC and Rx ophthalmic products due to a lack of sterility assurance.
Sun Pharmaceutical, P&L Developments and Preferred Pharmaceutical made OTCs for customers including CVS, Target and Walgreens. Latest updates to FDA recalls database also includes polypeptide- and colostrum-containing immunity support supplements made by APS BioGroup and Alterna anti-aging, moisture-replenishing conditioning milk and cream marketed by Henkel Corp.