Class II · Moderate risk
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Enablex (darifenacin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: unspecified degradation product
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Affected NDC
0078-9420-07
Compare with the code on your package — it is the most precise check available.
Drug: Darifenacin
- Recalling firm
- Warner Chilcott US LLC
- NDC code
- 0078-9420-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-822-2013 · 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 Darifenacin recalls
See all
Class II · Moderate risk
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Warner Chilcott US LLC
All 2013 recalls
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Jevantique
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Femtrace 0.45 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
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