Warner Chilcott Recalls Enablex Extended Release Tablets Due to Impurities
Warner Chilcott US LLC is recalling 188,600 bottles of Enablex (darifenacin) 15 mg extended-release tablets because they failed impurity specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall without specific reports of hospitalization or death is assigned a score of 4 (Severe).
Plain-English summary
Warner Chilcott US LLC is voluntarily recalling 188,600 bottles of Enablex (darifenacin) Extended Release Tablets, 15 mg. The affected product is the physician sample 7-tablet bottle, NDC 0078-9420-07, manufactured by Novartis Pharma Stein AG. The recall is limited to Lot F1002 with an expiration date of 12/13.
The recall was initiated because the product failed impurities/degradation specifications, specifically due to an unspecified degradation product. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled tablets and contact their healthcare provider or pharmacist for further instructions or a replacement.
The recalled product
- Product
- 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
- Manufacturer
- Warner Chilcott US LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 188,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot F1002 - Exp.12/13
Distribution
Distributed nationwide across the United States.
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