April 2018 FDA Recall Drug by Pharmedium Services, Llc
D-0632-2018 - cGMP deviations

This Class III drug recall was voluntarily initiated by Pharmedium Services, Llc on April 10, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in MA, WA and the recall is currently terminated.

Recall Number: D-0632-2018

Reason for Recall
cGMP deviations
Initiated
04-10-2018
Reported
04-25-2018
Quantity
72 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79799
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
MA, WA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2020
Product Description About Product Description
Full technical description of the product.
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478

Batch or Lot Expiration Information

Lot# Lot: 180660057S Exp. 6/5/2018