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# Professional E-mail Misbrands Renacidin
- URL: https://www.fdaweb.com/professional-e-mail-misbrands-renacidin/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137582

The CDER Office of Prescription Drug Promotion (OPDP) says that a professional e-mail for United-Guardian’s Renacidin (citric acid, glucono, delta-lactone, and magnesium carbonate) irrigation solution makes false or misleading claims or representations about the product’s risks and benefits, misbranding it. A 12/13 [Warning Letter](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM533540.pdf?ref=fdaweb.com) says Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. It also is indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

The labeling says that Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation and contains Warnings about fever, urinary tract infection, persistent flank pain, elevated serum creatinine, complications from inadequate aseptic technique, sepsis, and hypermagnesemia, and Precautions about patency of the urethral catheter or cyctostomy tube, vesicoureteral reflux, laboratory monitoring and concomitant use of medications containing magnesium.

OPDP says the e-mail contains multiple claims or representations about Renacidin, but fails to communicate any risk information. An e-mail link to the full prescribing information does not mitigate omission of the information from the e-mail itself, it says. The Warning Letter also says that the e-mail fails to cite references to support claims that Renacidin amplifies long-term care of in-dwelling catheters or is easy to use, and says that OPDP is not aware of such supporting evidence. Also, it says, the unsupported and thus misleading assertion that Renacidin has “easy 30 ml dosing and delivery” is exacerbated by the failure of the e-mail to reveal specific information from the label about how the drug should be dosed and administered.

United-Guardian was told to stop misbranding Renacidin and to respond with a list of violative promotional materials, a plan for discontinuing their use, and a plan to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to audiences that received the violative message.