D-1088-2014 Class III Terminated

Recalled by Actavis — Salt Lake City, UT

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