Multi-event July 2018 FDA Recall Drug by Pharmedium Services, Llc

This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on July 24, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.

Reported Recall Events

D-1043-2018 TERMINATED D-1045-2018 TERMINATED D-1044-2018 TERMINATED

Recall Number: D-1043-2018

Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Initiated
07-24-2018
Reported
08-15-2018
Quantity
230 Intravia Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80638
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-10-2018
Product Description About Product Description
Full technical description of the product.
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.

Batch or Lot Expiration Information

Lot# Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018

Recall Number: D-1045-2018

Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Initiated
07-24-2018
Reported
08-15-2018
Quantity
575 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80638
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-10-2018
Product Description About Product Description
Full technical description of the product.
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

Batch or Lot Expiration Information

Lot# Lot 181780003D

Recall Number: D-1044-2018

Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Initiated
07-24-2018
Reported
08-15-2018
Quantity
450 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80638
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-10-2018
Product Description About Product Description
Full technical description of the product.
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.

Batch or Lot Expiration Information

Lot# Lot 181730039D, Exp 09/20/2018