March 2013 FDA Recall Drug by Nuvision Pharmacy, Inc.
D-417-2013 - Lack of Assurance of Sterility; reports of adverse events after injection

This Class II drug recall was voluntarily initiated by Nuvision Pharmacy, Inc. on March 28, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; reports of adverse events after injection. The product was distributed in FL, MO, UT, and WA. and the recall is currently terminated.

Recall Number: D-417-2013

Reason for Recall
Lack of Assurance of Sterility; reports of adverse events after injection
Initiated
03-28-2013
Reported
05-22-2013
Quantity
32 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64722
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.
NuVision Pharmacy, Inc.
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.
FL, MO, UT, and WA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2016
Product Description About Product Description
Full technical description of the product.
Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244

Batch or Lot Expiration Information

Lot# Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014