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

FDA recall notice · announced August 13, 2014 · Sst

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: CA
Lot/code information: Lot: 168.862, Expiry: 6/2017
Quantity: 1 Drum
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.