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Recall Observatory FDA recall evidence

Drug product

Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2

D-1499-2020

August 04, 2020

Class II

Product summary

Firm
Eosera, Inc.
Event
Event 86171
Status
Terminated
Classification
Class II
Quantity
125,874 bottles
Official record key
drug-enforcement:D-1499-2020

Official wording

Reason: cGMP Deviations.

Code information: Lot #: P203076, P203075 Exp. NOV 21; P203061, P203057 Exp. AUG 21; P203047, P203044, P203040, JUL 21; P203033, P203030, P203016, P203015, P203002, P203001, P193053 Exp. JUN 21; P203024, P193097 Exp. MAY 21; P203017 Exp. JUL 20; P193091, P193089, P193088, P193087 Exp. APR 21; P193068, P193067 Exp. FEB 21; P193064, P193063, P193062, P193059, P193014 Exp. JAN 21; P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, Exp. DEC 20; P183018, P183017 Exp. SEP 20

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations