CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report

Multitrace-5 Injectable, all presentations recalled

Beacon Hill Medical Pharmacy, P.C is recalling Multitrace-5 Injectable, all presentations, For Intraveno and SQ Use Only, Sterile, distributed nationwide in the US. The recall was initiated on 26 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes02082013@10 and 07162013@10
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-982-2013
FDA event ID
65876
Recalling firm
Beacon Hill Medical Pharmacy, P.C, Southfield, MI
Classification
Class II
Status
Terminated
Recall initiated
26 Jul 2013
FDA classified
10 Sep 2013
Reported
18 Sep 2013
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

26 Jul 2013Recall initiated by company
10 Sep 2013Classified by FDA+46 days
18 Sep 2013Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Where it was distributed

USA nationwide

Nationwide

Questions about this recall

Is Multitrace-5 Injectable, all presentations, For Intraveno and SQ Use Only, Sterile recalled?

Yes. Beacon Hill Medical Pharmacy, P.C recalled Multitrace-5 Injectable, all presentations, For Intraveno and SQ Use Only, Sterile on 26 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-982-2013.

Why was it recalled?

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Which lots are affected?

02082013@10 and 07162013@10

Where was it sold?

USA nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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