The Recall Desk

FDA (Drugs) recall action 85186

Breckenridge Pharmaceutical, Inc recalled 2 products on 2020-03-25

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-25
Critical
0
Units
11,250

Why these products were recalled

CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the product converting to Solifenacin Tartrate.

    Product
    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 Pithampu
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.

    Product
    Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pith
    Category
    Distribution
    0 states