January 2017 FDA Recall Drug by Pharmedium Services, Llc
D-0603-2017 - Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

This Class III drug recall was voluntarily initiated by Pharmedium Services, Llc on January 27, 2017 for the product Drug. The FDA reported the reason for recall as labeling; label mixup; outer packaging is incorrectly labeled as buffered lidocaine 1% instead of correctly as buffered lidocaine 0.9%. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0603-2017

Reason for Recall
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Initiated
01-27-2017
Reported
03-22-2017
Quantity
3879 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76661
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
03-16-2017
Product Description About Product Description
Full technical description of the product.
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

Batch or Lot Expiration Information

Lot# Lot Numbers: 170110030M, 170110029M and 170070058M