FDA recall D-1057-2016

KVK-Tech, Inc. · Class III · drug

Product

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

Reason for recall

Discoloration: presence of scuffing marks on tablets.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-05-05
Report date
2016-07-06
Termination date
2017-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2016