FDAClass IIAugust 19, 2020

Ear Pain MD Pain Relief Drops with 4% Lidocaine recall: CGMP Deviations

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…

Why was Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled?

cGMP Deviations.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Eosera, Inc.
Quantity
125,874 bottles
Distribution
Nationwide within the United States
Recall date
August 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls