Why it was recalled
cGMP deviations
Product description
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Lot numbers, UPCs & expiration codes
Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
Where it was sold
Product was distributed USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0884-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2023
- FDA report date
- Jul 5, 2023
- Quantity
- 12,850 tottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Homeocare Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0884-2023, exactly as published.
Show all FDA fields
- City
- Yonkers
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92453
- Address
- 7 Odell Plz Ste 142-146
- Code information
- Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
- Postal code
- 10701-1407
- Report date
- Jul 5, 2023
- Product type
- Drugs
- Recall number
- D-0884-2023
- Classification
- Class II
- Recalling firm
- Homeocare Laboratories, Inc.
- Product quantity
- 12,850 tottles
- Termination date
- Sep 16, 2024
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
- Distribution pattern
- Product was distributed USA nationwide.
- Recall initiation date
- Jun 5, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2023