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

This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on February 5, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed to SC, FL, NY, NY,WA and the recall is currently terminated.

Reported Recall Events

D-0424-2018 TERMINATED D-0422-2018 TERMINATED D-0423-2018 TERMINATED

Recall Number: D-0424-2018

Reason for Recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Initiated
02-05-2018
Reported
02-21-2018
Quantity
500 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79063
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 to SC, FL, NY, NY,WA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2018
Product Description About Product Description
Full technical description of the product.
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC

Batch or Lot Expiration Information

Lot# : 180080063D, Exp 4/9/18

Recall Number: D-0422-2018

Reason for Recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Initiated
02-05-2018
Reported
02-21-2018
Quantity
24 Viaflex Bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79063
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 to SC, FL, NY, NY,WA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2018
Product Description About Product Description
Full technical description of the product.
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC

Batch or Lot Expiration Information

Lot# : 180040003D, Exp 3/18/18

Recall Number: D-0423-2018

Reason for Recall
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Initiated
02-05-2018
Reported
02-21-2018
Quantity
21 Cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79063
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 to SC, FL, NY, NY,WA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2018
Product Description About Product Description
Full technical description of the product.
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC

Batch or Lot Expiration Information

Lot# : 180030029D, Exp 2/18/18