June 2014 FDA Recall Drug by Pharmacy Creations
D-1546-2014 - Non-Sterility

This Class I drug recall was voluntarily initiated by Pharmacy Creations on June 25, 2014 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in NY, NJ, and Puerto Rico and the recall is currently terminated.

Recall Number: D-1546-2014

Reason for Recall
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Initiated
06-25-2014
Reported
08-27-2014
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68669
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmacy Creations
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.
NY, NJ, and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2016
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

Batch or Lot Expiration Information

Lot# Lot: 06062014@8, Do Not Use Beyond 12/03/2014