Class IITerminated

Fluocinolone Acetonide Oil recall

FDA recall D-0259-2024 · initiated Jan 4, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Details

Product: 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
Recalling company: Glenmark Pharms
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Jan 4, 2024
FDA report date: Jan 31, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0259-2024 ↗

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