D-0380-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- April 15, 2025
- Termination Date
- January 8, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,648 bottles
Product Description
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Reason for Recall
cGMP deviations
Distribution Pattern
DE
Code Information
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27