Novel Laboratories Recalls Fluocinolone Acetonide Topical Solution Due to Chemical Contamination
Novel Laboratories is recalling 7,656 bottles of Fluocinolone Acetonide Topical Solution 0.01% due to chemical contamination. The affected product was distributed nationwide.
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 recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Novel Laboratories, Inc. is recalling 7,656 bottles of Fluocinolone Acetonide Topical Solution USP 0.01%, 60 mL bottles, due to chemical contamination. The product is a prescription-only topical corticosteroid manufactured for Gavis Pharmaceuticals, LLC. The recall covers two specific lots: Lot # M15496 (Exp. 10/17) and Lot # M15507 (Exp. 12/17).
The affected product was distributed nationwide. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be discontinued and returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Novel Laboratories, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 7,656
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 (3)
- Lot # M15496
- Exp. 10/17 Lot # M15507
- Exp. 12/17
UPCs (1)
- 0343386069606
Distribution
Distributed nationwide across the United States.
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