Recall: D-0259-2024

Class II - Potentially Harmful

Class IIClassification

2024-01-04Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.