FDAFDA · Food and drugs·Recall number D-302-2013
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.
Published May 8, 2013 · Recall initiated: March 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 610593, Exp 06/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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