Drug 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
D-0259-2024
Product summary
- Event
- Event 93719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,496 bottles
- Official record key
drug-enforcement:D-0259-2024
Official wording
Reason: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Code information: Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol