Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Reported: April 3, 2013 Initiated: November 21, 2012 #D-218-2013
Product Description
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Reason for Recall
Subpotent; 22 month stability timepoint
Details
- Recalling Firm
- Hill Dermaceuticals, Inc.
- Units Affected
- 8,592 bottles
- Distribution
- Nationwide
- Location
- Sanford, FL
Frequently Asked Questions
What product was recalled? ▼
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04. Recalled by Hill Dermaceuticals, Inc.. Units affected: 8,592 bottles.
Why was this product recalled? ▼
Subpotent; 22 month stability timepoint
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2013. Severity: Low. Recall number: D-218-2013.
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