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# Cipro 100mg Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/cipro-100mg-withdrawn-due-to-safety-efficacy-fda/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157535

*Federal Register* notice: FDA has determined that Bayer’s Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn from sale due to safety or effectiveness reasons. The determination means the agency will not accept or approve ANDAs that reference the product. FDA says the drug’s effectiveness for treating acute uncomplicated cystitis is not supported by the current ciprofloxacin susceptibility test interpretive criteria (aka break points) established by the Clinical and Laboratory Standards Institute and recognized by FDA on 6/10/2019\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-08/pdf/2024-17650.pdf?ref=fdaweb.com).