Multi-event March 2013 FDA Recall Drug by Med Prep Consulting, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Med Prep Consulting, Inc. on March 14, 2013 for the product Drug. The FDA reported the reason for recall as non-sterility; mold contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-810-2013 TERMINATED D-811-2013 TERMINATED

Recall Number: D-810-2013

Reason for Recall
Non-Sterility; mold contamination
Initiated
03-14-2013
Reported
07-31-2013
Quantity
403883 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64640
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.
Med Prep Consulting, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2018
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-811-2013

Reason for Recall
Lack of Assurance of Sterility; potential for mold contamination
Initiated
03-14-2013
Reported
07-31-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64640
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.
Med Prep Consulting, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2018
Product Description About Product Description
Full technical description of the product.
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Batch or Lot Expiration Information

Lot# All lots