FDA-Drug2024-01-31Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Sold states
USA Nationwide
Affected count
38,496 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0259-2024Don't want to check this manually?
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