Why it was recalled
cGMP Deviations.
Product description
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
Lot numbers, UPCs & expiration codes
Lot #: P203076, P203075 Exp. NOV 21; P203061, P203057 Exp. AUG 21; P203047, P203044, P203040, JUL 21; P203033, P203030, P203016, P203015, P203002, P203001, P193053 Exp. JUN 21; P203024, P193097 Exp. MAY 21; P203017 Exp. JUL 20; P193091, P193089, P193088, P193087 Exp. APR 21; P193068, P193067 Exp. FEB 21; P193064, P193063, P193062, P193059, P193014 Exp. JAN 21; P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, Exp. DEC 20; P183018, P183017 Exp. SEP 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-1499-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 125,874 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eosera, Inc.
Original FDA data
Every field from FDA enforcement report D-1499-2020, 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
- Lot #: P203076, P203075 Exp. NOV 21; P203061, P203057 Exp. AUG 21; P203047, P203044, P203040, JUL 21; P203033, P203030, P203016, P203015, P203002, P203001, P193053 Exp. JUN 21; P203024, P193097 Exp. MAY 21; P203017 Exp. JUL 20; P193091, P193089, P193088, P193087 Exp. APR 21; P193068, P193067 Exp. FEB 21; P193064, P193063, P193062, P193059, P193014 Exp. JAN 21; P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, Exp. DEC 20; P183018, P183017 Exp. SEP 20
- Postal code
- 76115-3902
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1499-2020
- Classification
- Class II
- Recalling firm
- Eosera, Inc.
- Product quantity
- 125,874 bottles
- Termination date
- Sep 10, 2021
- Reason for recall
- cGMP Deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2020