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