September 2016 FDA Recall Drug by Guardian Pharmacy Services
D-0211-2017 - Non-Sterility

This Class I drug recall was voluntarily initiated by Guardian Pharmacy Services on September 23, 2016 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in Two medical facilities in TX and the recall is currently terminated.

Recall Number: D-0211-2017

Reason for Recall
Non-Sterility: failed sterility test result.
Initiated
09-23-2016
Reported
12-28-2016
Quantity
180 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75268
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Guardian Pharmacy Services
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.
Two medical facilities in TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

Batch or Lot Expiration Information

Lot# : 50699:00, Exp 10/04/16