FDA recall D-1517-2014

SST Corporation · Class II · drug

Product

Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5

Reason for recall

CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Distribution

CA

Key facts

Status: Terminated
Initiation date: 2014-07-17
Report date: 2014-08-13
Termination date: 2016-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Clifton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2014