Reported Mar 25, 2020 · Terminated
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC…
Breckenridge Pharmaceutical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352
Is this the product you have?
- Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90)
- Distributed byBreckenridge Pharmaceutical, Inc. Boca Raton, FL 33487
- Manufactured byPiramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
- Lot codes and dates
Lot #: a) 8124481217Exp. Date 01/2021 and b) 81245Exp. Date 01/2021
- Amount recalled
- 11,250 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
This product could cause temporary or reversible health problems — stop using it.
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