D-0259-2024 Class II Terminated
FDA drug recall D-0259-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on Jan 4, 2024 and is designated Class II. Reason for recall: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol The recall status is terminated (terminated Aug 16, 2024). Affected quantity: 38,496 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 31, 2024
- Initiation Date
- Jan 4, 2024
- Termination Date
- Aug 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,496 bottles
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
Reason for Recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Distribution Pattern
USA Nationwide
Code Information
Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0259-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026