CLASS III Drug recall · Reported 8 Jan 2014 · FDA Enforcement Report
G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm recalled
G & W Laboratories is recalling G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (, distributed nationwide in the US. The recall was initiated on 30 Sep 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-391-2014
- FDA event ID
- 66454
- Recalling firm
- G & W Laboratories, South Plainfield, NJ
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Sep 2013
- FDA classified
- 27 Dec 2013
- Reported
- 8 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 30 Sep 2013 | Recall initiated by company | |
| 27 Dec 2013 | Classified by FDA | +88 days |
| 8 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications; at the 18 month time point.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications; at the 18 month time point.
Which lots are affected?
15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Fluocinolone Acetonide recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package recalledFluocinolone Acetonide | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution, USP, 0.01 % recalledFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |