FDA recall D-0255-2015
Spectrum Laboratory Products · Class II · drug
Product
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Reason for recall
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Distribution
U.S.: California.
Key facts
- Status
- Terminated
- Initiation date
- 2014-07-18
- Report date
- 2014-11-26
- Termination date
- 2014-11-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Gardena, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2015