FDA recall D-302-2013

Hi-Tech Pharmacal Co., Inc. · Class III · drug

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.

Reason for recall

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-03-11
Report date
2013-05-08
Termination date
2016-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-302-2013