FDA recall D-0817-2016

Biocon Inc · Class III · drug

Product

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

Reason for recall

Subpotent Drug

Distribution

PA, CA, & OH

Key facts

Status: Terminated
Initiation date: 2016-03-24
Report date: 2016-04-20
Termination date: 2017-12-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Iselin, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2016