Hydrocortisone and Acetic Acid Otic Solution recall: Subpotent
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Why was Hydrocortisone and Acetic Acid Otic Solution recalled?
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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 #: 364667, Exp 12/20/2019
- Product
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
- Recalling firm
- Akorn Inc
- Quantity
- 16,078 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)