Why it was recalled
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Product description
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Lot numbers, UPCs & expiration codes
Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22
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-0637-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2021
- FDA report date
- Jun 30, 2021
- Quantity
- 34,561 bottles for sale; 773 bottles for samples
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0637-2021, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87990
- Address
- 2650 S Mellonville Ave
- Code information
- Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22
- Postal code
- 32773-9311
- Report date
- Jun 30, 2021
- Product type
- Drugs
- Recall number
- D-0637-2021
- Classification
- Class II
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 34,561 bottles for sale; 773 bottles for samples
- Termination date
- Sep 28, 2022
- Reason for recall
- Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 21, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2021