FDAFDA · Food and drugs·Recall number D-1501-2020
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
Published August 19, 2020 · Recall initiated: August 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Eosera, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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