D-0584-2021 Class II Terminated
FDA drug recall D-0584-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 37 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution Pattern
FL, GA, SC
Code Information
BDZ9G005