Drug 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.
D-1088-2014
Product summary
- Firm
- Actavis
- Event
- Event 67457
- Status
- Terminated
- Classification
- Class III
- Quantity
- 38,227 Clamshells
- Official record key
drug-enforcement:D-1088-2014
Official wording
Reason: Subpotent Drug: Drug potency was compromised during shipment.
Code information: Lot #: 514656; Expiry: 03/14
Distribution pattern: Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Derived failure modes
-
Potency or specification failure
Subpotent