Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP recall: Impurity Out of Spec
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT…
Why was Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP recalled?
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
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# AC86809, AC86812, Exp Date: 01/31/2024
- Product
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT…
- Recalling firm
- Taro Pharmaceuticals Inc.
- Quantity
- 11,196 bottles
- Distribution
- Nationwide in the USA
- Recall date
- November 15, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)