Aaron M. Schneider
Chief Pharmacy Officer & Owner
Revive Rx LLC dba Revive Rx Pharmacy
3831 Golf Drive, Suite A
Houston , TX 77018-5218
United StatesFEI 3016710945Issued Sep 22, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016710945.
Violations2
Issue DateSep 22, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Revive Rx LLC dba Revive Rx Pharmacy
Location
Aaron M. Schneider
Chief Pharmacy Officer & Owner
Revive Rx LLC dba Revive Rx Pharmacy
3831 Golf Drive, Suite A
Houston , TX 77018-5218
United States
FEI Number
3016710945
Country
United States
Issue Date
September 22, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Revive Rx LLC dba Revive Rx Pharmacy, a compounding pharmacy in Houston, Texas, was cited for producing adulterated sterile drug products under insanitary conditions that violated federal manufacturing standards. During an inspection from January 27 to February 7, 2025, FDA investigators documented that the pharmacy exposed sterile drug products to air quality worse than required ISO standards and failed to perform adequate product evaluation and corrective actions following microbial contamination recovery. These deficiencies violated Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act and put patients at risk by potentially compromising product sterility and safety.
Revive Rx LLC dba Revive Rx Pharmacy FDA Warning Letter, September 22, 2025
Talk to a Specialist