August 2013 FDA Recall Drug by Creative Compounds
D-1019-2013 - Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.

This Class II drug recall was voluntarily initiated by Creative Compounds on August 23, 2013 for the product Drug. The FDA reported the reason for recall as glutathione 100 mg/ml injectable human drug is recalled due to out of specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.. The product was distributed in Oregon and Washington and the recall is currently terminated.

Recall Number: D-1019-2013

Reason for Recall
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Initiated
08-23-2013
Reported
09-18-2013
Quantity
16 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66084
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.
Creative Compounds
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Oregon and Washington
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2013
Product Description About Product Description
Full technical description of the product.
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

Batch or Lot Expiration Information

Lot# : 20130715@12, Exp10/13/2013