Product: Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated: 20210315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated