Multi-event January 2015 FDA Recall Drug by Pharmedium Services, Llc

This Multi-event Class I drug recall was voluntarily initiated by Pharmedium Services, Llc on January 13, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK. and the recall is currently terminated.

Reported Recall Events

D-723-2016 TERMINATED D-724-2016 TERMINATED

Recall Number: D-723-2016

Reason for Recall
Subpotent Drug
Initiated
01-13-2015
Reported
02-24-2016
Quantity
180 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72380
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.
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2016
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.

Batch or Lot Expiration Information

Lot# : 15002077M, Exp 04-02-2015

Recall Number: D-724-2016

Reason for Recall
Subpotent Drug
Initiated
01-13-2015
Reported
02-24-2016
Quantity
500 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72380
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.
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2016
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium

Batch or Lot Expiration Information

Lot# : 15002250M, Exp 04-02-2015