May 2013 FDA Recall Drug by Abrams Royal Pharmacy
D-0252-2015 - Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

This Class I drug recall was voluntarily initiated by Abrams Royal Pharmacy on May 13, 2013 for the product Drug. The FDA reported the reason for recall as non-sterility; contract laboratory identified staphylococcus warneri in the product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0252-2015

Reason for Recall
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Initiated
05-13-2013
Reported
11-26-2014
Quantity
21 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68345
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 Pharmacy
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.
Nationwide
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.
Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

Batch or Lot Expiration Information

Lot# Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013