Drug recall D-0583-2021
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.
Lots and codes
BDZ7G005
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 52 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Darifenacin – drug information
- NDC 13668-202 Darifenacin · Darifenacin Hydrobromide 7.5 mg/1 · Torrent Pharmaceuticals Limited
- NDC 13668-203 Darifenacin · Darifenacin Hydrobromide 15 mg/1 · Torrent Pharmaceuticals Limited