D-1517-2014 Class II Terminated
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