FDA-Drug2013-05-08Class III
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.
Hi-Tech Pharmacal Co., Inc.
Hazard
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Sold states
Nationwide and Puerto Rico
Affected count
11,472 bottles
Manufactured in
369 Bayview Ave, Amityville, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-302-2013Don't want to check this manually?
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