Home / Recalls / Eosera, Inc. / D-1498-2020

D-1498-2020 Class II Terminated

Recalled by Eosera, Inc. — Fort Worth, TX

FDA drug recall D-1498-2020 was initiated by Eosera, Inc. on August 4, 2020 and is designated Class II. Reason for recall: cGMP Deviations. The recall status is terminated (terminated September 10, 2021). Affected quantity: 45,673 bottles.

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
45,673 bottles

Product Description

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

Reason for Recall

cGMP Deviations.

Distribution Pattern

Nationwide within the United States

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

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-1499-2020 Class II — Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0 (August 4, 2020)

FDA data resources