Hi-Tech Pharmacal Co., Inc. recalls Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-88
Recalled May 8, 2013 · FDA recall D-302-2013 · Hi-Tech Pharmacal
Hazard
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. · FDA Class III
Units
11,472 bottles
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
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.
Manufacturer(s)
Hi-Tech Pharmacal Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →