August 2016 FDA Recall Drug by Spectrum Laboratory Products, Inc.
D-1456-2016 - Does not meet monograph

This Class II drug recall was voluntarily initiated by Spectrum Laboratory Products, Inc. on August 1, 2016 for the product Drug. The FDA reported the reason for recall as does not meet monograph. The product was distributed in US: MA, TN, GA, MO and Canada and the recall is currently terminated.

Recall Number: D-1456-2016

Reason for Recall
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Initiated
08-01-2016
Reported
08-17-2016
Quantity
14,000 grams

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74888
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spectrum Laboratory Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: MA, TN, GA, MO and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2017
Product Description About Product Description
Full technical description of the product.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

Batch or Lot Expiration Information

Lot# 2EH0257