Home / Recalls / Eosera, Inc. / D-1499-2020

D-1499-2020 Class II Terminated

Recalled by Eosera, Inc. — Fort Worth, TX

Recall Details

Product Type
Drugs
Report Date
August 19, 2020
Initiation Date
August 4, 2020
Termination Date
September 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
125,874 bottles

Product Description

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

Reason for Recall

cGMP Deviations.

Distribution Pattern

Nationwide within the United States

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

Other recalls by Eosera, Inc.

  • D-1500-2020 Class II — Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera (August 4, 2020)
  • D-1501-2020 Class II — Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 m (August 4, 2020)
  • D-1498-2020 Class II — Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (August 4, 2020)