Class II · Moderate risk
Solifenacin Succinate Tablets 5mg
CGMP Deviations
Solifenacin Succinate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
Affected NDC
69097-0261-02
Compare with the code on your package — it is the most precise check available.
Drug: Solifenacin
- Recalling firm
- Cipla
- NDC code
- 69097-261-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0660-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Solifenacin recalls
See all
Class II · Moderate risk
Solifenacin Succinate Tablets 10MG
CGMP Deviations
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
SOLIFENACIN SUCCINATE Tablet
Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.
Other recalls by Cipla
All 2021 recalls
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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