FDA recall D-0259-2024

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

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-01-04

Report date

2024-01-31

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0259-2024