FDA Drug recall D-1088-2014
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only
- FDA Drug
- Class III
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class III recall of Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only by Actavis, citing subpotent Drug: Drug potency was compromised during shipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1088-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-02-07 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
Subpotent Drug: Drug potency was compromised during shipment.
Identifiers
| code_info | Lot #: 514656; Expiry: 03/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1088-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.