Home / Recalls / Eosera, Inc. / D-1501-2020

D-1501-2020 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
15229 bottles

Product Description

Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5

Reason for Recall

cGMP Deviations.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21

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-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)