May 2016 FDA Recall Drug by Pharmedium Services, Llc
D-0976-2016 - Labeling

This Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on May 16, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in NY and the recall is currently terminated.

Recall Number: D-0976-2016

Reason for Recall
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Initiated
05-16-2016
Reported
06-15-2016
Quantity
240 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74299
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-22-2016
Product Description About Product Description
Full technical description of the product.
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.

Batch or Lot Expiration Information

Lot# 161300033M, Exp 07/26/16