D-1517-2014 Class II Terminated

Recalled by SST Corporation — Clifton, NJ

Recall Details

Product Type
Drugs
Report Date
August 13, 2014
Initiation Date
July 17, 2014
Termination Date
August 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 Drum

Product Description

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 Pattern

CA

Code Information

Lot: 168.862, Expiry: 6/2017