Fluocinolone Acetonide Oil recall
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.…
Why was Fluocinolone Acetonide Oil recalled?
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
- Product
- Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 38,496 bottles
- Distribution
- USA Nationwide
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)