Recalling firm
Pharmadel, LLC
Product type
Drug
Status
Terminated
Report date
2025-04-30
Distribution
DE
Firm state
DE
Product quantity
27,648 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations
Product description
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Code / lot info
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.