D-1088-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 5, 2014
- Initiation Date
- February 7, 2014
- Termination Date
- September 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