Hydrocortisone and Acetic Acid Otic Solution recall: Labeling Error
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal…
Why was Hydrocortisone and Acetic Acid Otic Solution recalled?
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
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 # 346191, Exp. 12/2016
- Product
- Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal…
- Recalling firm
- Akorn, Inc.
- Quantity
- 13,896 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- November 25, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)