Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 514656; Expiry: 03/14
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Actavis
- Reason for Recall:
- Subpotent Drug: Drug potency was compromised during shipment.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
Product Codes/Lot Numbers:
Lot #: 514656; Expiry: 03/14
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1088-2014
Related Recalls
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Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.