Multi-event December 2013 FDA Recall Drug by Abrams Royal Pharamacy

This Multi-event Class I drug recall was voluntarily initiated by Abrams Royal Pharamacy on December 19, 2013 for the product Drug. The FDA reported the reason for recall as non-sterility; analytical results found product to contain sphingomonas paucimobilis. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1563-2014 TERMINATED D-1564-2014 TERMINATED

Recall Number: D-1563-2014

Reason for Recall
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Initiated
12-19-2013
Reported
09-03-2014
Quantity
74

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67135
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.
Abrams Royal Pharamacy
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.
Nationwide and to Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

Batch or Lot Expiration Information

Lot# Lot number 11142013@74

Recall Number: D-1564-2014

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-19-2013
Reported
09-03-2014
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67135
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.
Abrams Royal Pharamacy
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.
Nationwide and to Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-07-2016
Product Description About Product Description
Full technical description of the product.
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX

Batch or Lot Expiration Information

Lot# All unexpired lots of sterile drug products