G & W Fluocinolone Acetonide Cream Recalled for Content Uniformity Failure
G & W Laboratories is recalling Fluocinolone Acetonide Cream 0.025% because it failed content uniformity specifications at the 18-month time point.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a failure in content uniformity specifications, a quality control defect rather than an acute safety hazard like contamination or mislabeling.
Plain-English summary
G & W Laboratories Inc. is voluntarily recalling Fluocinolone Acetonide Cream USP 0.025% in 15 gm and 60 gm metal tubes. The recall was initiated because the product failed content uniformity specifications at the 18-month time point. The affected product is a prescription-only topical corticosteroid manufactured by G & W Laboratories, Inc. in South Plainfield, New Jersey.
The recall covers 187,368 metal tubes distributed nationwide. Specific lot numbers for the 15 gm and 60 gm sizes are listed in the official recall notice. The product is identified by NDC codes 0713-0222-15 and 0713-0222-60.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- G & W Laboratories Inc
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 187,368
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
UPCs (1)
- 022212012022
Distribution
Distributed nationwide across the United States.
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