FDAFDA · Food and drugs·Recall number D-1050-2020
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
Published March 25, 2020 · Recall initiated: January 24, 2020
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: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Distributor
- Product was distributed nationwide within the United States.
- Lot
- Lot #: a) 81244, 81217, Exp. Date 01/2021 and b) 81245, Exp. Date 01/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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