May 2015 FDA Recall Drug by Pharmedium Services, Llc
D-0658-2016 - Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

This Class I drug recall was voluntarily initiated by Pharmedium Services, Llc on May 22, 2015 for the product Drug. The FDA reported the reason for recall as sub-potent drug; firm's analysis revealed subpotent result for morphine sulfate assay.. The product was distributed in WI and the recall is currently terminated.

Recall Number: D-0658-2016

Reason for Recall
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Initiated
05-22-2015
Reported
02-17-2016
Quantity
19 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72478
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.
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.
WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-18-2016
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.

Batch or Lot Expiration Information

Lot# :151370066M, Exp. 08/15/2015