Class II
Terminated
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
- Recall Initiated
- January 4, 2024
- Posted
- January 31, 2024
- Recall Number
- D-0259-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38,496 bottles
- Firm Location
- Mahwah, NJ, United States
Reason for Recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Distribution
USA Nationwide
Lot / Code Info
Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
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