Recalls / Class II
Class IID-0884-2023
Product
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
- Affected lot / code info
- Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Homeocare Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Odell Plz Ste 142-146, N/A, Yonkers, New York 10701-1407
Distribution
- Quantity
- 12,850 tottles
- Distribution pattern
- Product was distributed USA nationwide.
Timeline
- Recall initiated
- 2023-06-05
- FDA classified
- 2023-06-26
- Posted by FDA
- 2023-07-05
- Terminated
- 2024-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0884-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.