FDA-Drug2014-03-05Class III

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.

Actavis
Hazard

Subpotent Drug: Drug potency was compromised during shipment.

Sold states
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Affected count
38,227 Clamshells
Manufactured in
575/577/579 Chipeta Way, Salt Lake City, UT, United States
Products
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.

Official notice

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

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