ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Reported: April 2, 2014 Initiated: January 31, 2014 #D-1178-2014
Product Description
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20
Reason for Recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Details
- Recalling Firm
- Hill Dermaceuticals, Inc.
- Units Affected
- 13,379 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Sanford, FL
Frequently Asked Questions
What product was recalled? ▼
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20. Recalled by Hill Dermaceuticals, Inc.. Units affected: 13,379 bottles.
Why was this product recalled? ▼
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 2, 2014. Severity: Low. Recall number: D-1178-2014.
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