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.
G & W Fluocinolone Acetonide Cream USP 0.025%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications; at the 18 month time point.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
Affected NDCs
0713-0222-15
0713-0222-60
Compare with the code on your package — it is the most precise check available.
Drug: Fluocinolone
- Recalling firm
- G & W Laboratories Inc
- NDC code
- 0713-0222-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-391-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 G & W Laboratories Inc
All 2013 recalls
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk
G & W Clobetasol Propionate Ointment 0.05%
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
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