Drug product
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
D-0421-2018
Product summary
- Event
- Event 79172
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 bottle
- Official record key
drug-enforcement:D-0421-2018
Official wording
Reason: CGMP Deviations: not manufactured according to current good manufacturing practices.
Code information: Lot: 17JXIII, Exp. 12/31/2019
Distribution pattern: NY
Derived failure modes
-
Manufacturing or process control
CGMP Deviations