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.

FDA recall notice · announced March 5, 2014 · Actavis

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Lot/code information: Lot #: 514656; Expiry: 03/14
Quantity: 38,227 Clamshells
Status: Terminated
Products in this recall event:
- 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, (D-1088-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.