PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: March 5, 2014 Initiated: February 7, 2014 #D-1088-2014

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.

Details

Recalling Firm
Actavis
Units Affected
38,227 Clamshells
Distribution
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Actavis. Units affected: 38,227 Clamshells.
Why was this product recalled?
Subpotent Drug: Drug potency was compromised during shipment.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 5, 2014. Severity: Low. Recall number: D-1088-2014.