Breckenridge Pharmaceutical Solifenacin Succinate Tablets, 5mg recall — FDA D-1050-2020
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Overview of recall records associated with Breckenridge Pharmaceutical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 25, Class III: 3.
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
This page summarizes recall records in which the official source identifies Breckenridge Pharmaceutical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.