June 2018 FDA Recall Drug by Pharmedium Services, Llc
D-0854-2018 - Superpotent and Subpotent

This Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on June 5, 2018 for the product Drug. The FDA reported the reason for recall as superpotent and subpotent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0854-2018

Reason for Recall
Superpotent and Subpotent
Initiated
06-05-2018
Reported
06-20-2018
Quantity
2,800 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80251
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2019
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ

Batch or Lot Expiration Information

Lot# Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018