July 2015 FDA Recall Drug by Pharmedium Services, Llc
D-1428-2015 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on July 21, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in VA, IL, PA, ID and the recall is currently terminated.

Recall Number: D-1428-2015

Reason for Recall
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Initiated
07-21-2015
Reported
09-16-2015
Quantity
120 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71892
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.
Pharmedium Services, LLC
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.
VA, IL, PA, ID
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2015
Product Description About Product Description
Full technical description of the product.
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48

Batch or Lot Expiration Information

Lot# : 151900249M, Exp 09/09/15