Drug product
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
D-1501-2020
Product summary
- Firm
- Eosera, Inc.
- Event
- Event 86171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15229 bottles
- Official record key
drug-enforcement:D-1501-2020
Official wording
Reason: cGMP Deviations.
Code information: Lot #: TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations