Drug product
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30
D-0584-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 bottles
- Official record key
drug-enforcement:D-0584-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: BDZ9G005
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations