June 2017 FDA Recall Drug by Medpark Pharmacy, Llc
D-0888-2017 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Medpark Pharmacy, Llc on June 1, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Distributed to patient in Maryland and the recall is currently terminated.

Recall Number: D-0888-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
06-01-2017
Reported
06-14-2017
Quantity
1 (5mL) vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77428
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.
MedPark Pharmacy, 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.
Distributed to patient in Maryland
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2018
Product Description About Product Description
Full technical description of the product.
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401

Batch or Lot Expiration Information

Lot# : 20170323-01, Exp.09/18/2017