D-1088-2014 Class III Terminated
FDA drug recall D-1088-2014 was initiated by Actavis on Feb 7, 2014 and is designated Class III. Reason for recall: Subpotent Drug: Drug potency was compromised during shipment. The recall status is terminated (terminated Sep 5, 2014). Affected quantity: 38,227 Clamshells.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 5, 2014
- Initiation Date
- Feb 7, 2014
- Termination Date
- Sep 5, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,227 Clamshells
Product 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.
Reason for recall
Subpotent Drug: Drug potency was compromised during shipment.
Distribution pattern
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Code information
Lot #: 514656; Expiry: 03/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1088-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026