FDA recall D-1088-2014

Product

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

Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.

Key facts

Status

Terminated

Initiation date

2014-02-07

Report date

2014-03-05

Termination date

2014-09-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1088-2014