Novel Laboratories, Inc. recalls Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only,…
- Recall date
- February 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0653-2017
- FDA classification
- Class III
- Brand / firm
- Novel Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Chemical Contamination
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
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