Why it was recalled
cGMP Deviations.
Product description
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
Lot numbers, UPCs & expiration codes
Lots: P203093 Exp. DEC 21; P203026 Exp. JUN 21; P193084, P193044, Exp. APR 21; P193073, P193072, P193071, P193070 Exp. FEB 21; P192050 Exp. MAY 21; P193042 Exp. MAR 21; P193013 Exp. JAN 21; P193012 Exp. DEC 20
Where it was sold
Nationwide within the United States
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-1498-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 45,673 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eosera, Inc.
Original FDA data
Every field from FDA enforcement report D-1498-2020, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86171
- Address
- 5000 South Fwy Ste 106
- Code information
- Lots: P203093 Exp. DEC 21; P203026 Exp. JUN 21; P193084, P193044, Exp. APR 21; P193073, P193072, P193071, P193070 Exp. FEB 21; P192050 Exp. MAY 21; P193042 Exp. MAR 21; P193013 Exp. JAN 21; P193012 Exp. DEC 20
- Postal code
- 76115-3902
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1498-2020
- Classification
- Class II
- Recalling firm
- Eosera, Inc.
- Product quantity
- 45,673 bottles
- Termination date
- Sep 10, 2021
- Reason for recall
- cGMP Deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2020