Reported Jan 31, 2024 · Terminated
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by:…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only
- Manufactured byGlenmark Pharmaceuticals Ltd
- VillageKishanpura, Baddi Nalagarh Road
- DistrictSolan, Himachal Pradesh - 173205, India
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
- Lot codes and dates
Lot #: 0522034605220369 Exp 1/31/ 202405220582Exp 2/29/202405220861 Exp 3/31/2024
- Amount recalled
- 38,496 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
This product could cause temporary or reversible health problems — stop using it.
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