Hill Dermaceuticals, Inc.: Drug Recall
Recall #D-0637-2021 · 05/21/2021
Class II: Risk
Recall Details
- Recall Number
- D-0637-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Hill Dermaceuticals, Inc.
- Status
- Terminated
- Date Initiated
- 05/21/2021
- Location
- Sanford, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,561 bottles for sale; 773 bottles for samples
Reason for Recall
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
Distribution Pattern
Nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.