Drug earache drops recalled due to manufacturing practice deviations
DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall was voluntary and precautionary, based on manufacturing deviations rather than a confirmed contamination or adverse event. Voluntary precautionary recalls without reported harm meet the criteria for Moderate severity.
Plain-English summary
DoloEar Earache Drops, 0.50 fl. oz. bottles, manufactured by Homeocare Laboratories, Inc. and distributed by Pharmadel LLC in Georgetown, Delaware, are being recalled due to deviations from current Good Manufacturing Practice (cGMP) standards.
Approximately 12,850 bottles were distributed nationwide across the United States. The affected product includes Lot # 2423 (expiration date November 2024) and Lot # 2445 (expiration date April 2025), identified by NDC 55758-001-15.
Homeocare Laboratories voluntarily initiated the recall on June 5, 2023, following FDA notification on June 26, 2023. The recall was terminated on September 16, 2024. Consumers who have purchased affected lots should stop using the product and consult their healthcare provider if they have taken this medication.
The recalled product
- Product
- DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Otic
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 2423
- exp. date Nov-24
- 2445
- exp. date Apr-25
Distribution
Distributed nationwide across the United States.
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