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
Reported: June 30, 2021 Initiated: May 21, 2021 #D-0637-2021
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
Reason for Recall
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Details
- Recalling Firm
- Hill Dermaceuticals, Inc.
- Units Affected
- 34,561 bottles for sale; 773 bottles for samples
- Distribution
- Nationwide within the United States
- Location
- Sanford, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hill Dermaceuticals, Inc.. Units affected: 34,561 bottles for sale; 773 bottles for samples.
Why was this product recalled? ▼
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 30, 2021. Severity: Moderate. Recall number: D-0637-2021.
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