December 2014 FDA Recall Drug by Right Value Drug Stores, Inc.
D-0335-2015 - Incorrect Product Formulation

This Class II drug recall was voluntarily initiated by Right Value Drug Stores, Inc. on December 12, 2014 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed in KS, MO, and TX. and the recall is currently terminated.

Recall Number: D-0335-2015

Reason for Recall
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Initiated
12-12-2014
Reported
01-14-2015
Quantity
a) 26 vials, b) 15 vials, c) 16 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70003
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.
Right Value Drug Stores, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
KS, MO, and TX.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-23-2016
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.

Batch or Lot Expiration Information

Lot# : 11142014@5, 10142014@17, 11032014@13, 08262014@6, 09162014@6, 06272014@12, 08052014@5, 07222014@18, 07222014@3, 06262014@11, 06182014@3