July 2014 FDA Recall Drug by Sst Corporation
D-1517-2014 - CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
This Class II drug recall was voluntarily initiated by Sst Corporation on July 17, 2014 for the product Drug. The FDA reported the reason for recall as cgmp deviations; stored/dispensed in a non-gmp compliant warehouse at s.i.m.s., italy.. The product was distributed in CA and the recall is currently terminated.
Recall Number: D-1517-2014
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
07-17-2014
08-13-2014
1 Drum
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SST Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CA
08-04-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot: 168.862, Expiry: 6/2017
