Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
HI-LITE Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Drug: Fluocinolone
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0560-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluocinolone recalls
See all
Class II · Moderate risk
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by Synergy Rx
All 2017 recalls
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Intimate Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Custom Lightening/Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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