FDAFDA · Food and drugs·Recall number D-0584-2021
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
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DARIFENACIN
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- UPC
- 0313668202304
- Lot
- BDZ9G005
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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