Drug Recall: 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:
Glenmark Pharmaceuticals Inc., USA · January 4, 2024
Reason for Recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Product Description
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
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
38,496 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0259-2024
Status: terminated
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