Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

FDA recall notice · announced October 31, 2018 · 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%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# M16666, EXP 12/2018
Quantity: 2712 60-ml bottles
Status: Terminated
Products in this recall event:
- Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 4338 (D-0092-2019)

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