Drug product
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
D-1500-2020
Product summary
- Firm
- Eosera, Inc.
- Event
- Event 86171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,424 bottles
- Official record key
drug-enforcement:D-1500-2020
Official wording
Reason: cGMP Deviations.
Code information: Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations