Acetic Acid Otic Solution recall: Subpotent
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Why was Acetic Acid Otic Solution recalled?
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
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 #: 610593, Exp 06/13
- Product
- Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Quantity
- 11,472 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- May 8, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)