FDAFDA · Food and drugs·Recall number D-0092-2019
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
Published October 31, 2018 · Recall initiated: October 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- LUPIN SOMERSET
- Distributor
- Nationwide in the USA
- UPC
- 0343386069606
- Lot
- Lot# M16666, EXP 12/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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