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

FDA recall notice · announced August 19, 2020 · Eosera

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP Deviations.

Notes

Distribution: Nationwide within the United States
Lot/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
Quantity: 43,424 bottles
Status: Terminated
Products in this recall event:
- 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. 50 (D-1501-2020)
- 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 (D-1499-2020)
- 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 (D-1498-2020)
- 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 (D-1500-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.