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.

FDA recall notice · announced January 30, 2019 · Lupin Somerset

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20
Quantity: 24,180 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0390-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.