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
D-1517-2014
Product summary
- Firm
- SST Corporation
- Event
- Event 68891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Drum
- Official record key
drug-enforcement:D-1517-2014
Official wording
Reason: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Code information: Lot: 168.862, Expiry: 6/2017
Distribution pattern: CA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations