Drug product
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
D-1498-2020
Product summary
- Firm
- Eosera, Inc.
- Event
- Event 86171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,673 bottles
- Official record key
drug-enforcement:D-1498-2020
Official wording
Reason: cGMP Deviations.
Code information: Lots: P203093 Exp. DEC 21; P203026 Exp. JUN 21; P193084, P193044, Exp. APR 21; P193073, P193072, P193071, P193070 Exp. FEB 21; P192050 Exp. MAY 21; P193042 Exp. MAR 21; P193013 Exp. JAN 21; P193012 Exp. DEC 20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations