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
Reason for recall: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Recall initiated: 20240104
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated