Home / Recalls / Eosera, Inc. / D-1500-2020

D-1500-2020 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
43,424 bottles

Product Description

Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125

Reason for Recall

cGMP Deviations.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20

Other recalls by Eosera, Inc.

  • 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)
  • D-1498-2020 Class II — Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (August 4, 2020)