FDA-Drug2019-01-30Class II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
LUPIN SOMERSET
Hazard
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
24,180 bottles
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2019Don't want to check this manually?
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