Glenmark Pharmaceuticals Inc., USA recalls Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Gl
Recalled January 31, 2024 · FDA recall D-0259-2024 · Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol · FDA Class II
Units
38,496 bottles
Sold at
USA Nationwide
Description
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →