FDA recall D-389-2014

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

Product

Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.

Reason for recall

Failed Stability Specification; product viscosity and or pH are below specification.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-10-28
Report date: 2014-01-01
Termination date: 2016-05-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-389-2014