FDAFDA · Food and drugs·Recall number D-0259-2024
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Published January 31, 2024 · Recall initiated: January 4, 2024
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 Excipient Specifications: OOS for assay of Isopropyl Alcohol
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- USA Nationwide
- Lot
- Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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