Additional safety information available:
Dry Eye Foundation has determined that Retaine PM is manufactured by Galentic Pharma (India) Pvt Limited with FEI 3012178852. This facility's most recent FDA inspection was completed on December 8 2022. Numerous inspection citations indicate an overall failure to properly design, implement and monitor sterile manufacturing processes. These citations include, but are not limited to: 1) failure to establish and implement procedures for cleaning and maintenance of equipment, 2) failure to establish, validate and follow written procedures to ensure sterility of drug products, 3) failure to establish scientifically sound laboratory methods to ensure that finished drug products are accurately formulated, 4) failure to properly investigate identified discrepancies, and 5) failure to adequately train employees. These citations are similar in language and meaning to those found in the recent inspections of Global Pharma Healthcare Pvt Ltd, Kilitch Healthcare India Limited and KC Pharmaceuticals. Accordingly, although the FDA has not made any public statements about Retaine PM or Galentic Pharma, the Foundation considers this product to be at risk for misformulation, adulteration or bacterial contamination. This information is provided to assist consumers in making informed choices about their eye care products.