July 2014 FDA Recall Drug by Spectrum Laboratory Products
D-0255-2015 - 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 Spectrum Laboratory Products on July 18, 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 U.S.: California. and the recall is currently terminated.
Recall Number: D-0255-2015
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
07-18-2014
11-26-2014
16 Bottles
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.
Spectrum Laboratory Products
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.: California.
11-24-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Batch or Lot Expiration Information
Lot# : 1BJ0479; Expiry: 06/2017
