CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report

NA Ascorbate 500 mg/mL, PF, Medaus Pharmacy 1 recalled

Medaus is recalling NA Ascorbate 500 mg/mL, PF, Medaus Pharmacy 1-800-526-9183, distributed nationwide in the US. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT # 130702-1, Exp 12/29/2013
Quantity recalled15,500 mL

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-1054-2013
FDA event ID
66172
Recalling firm
Medaus, Birmingham, AL
Classification
Class II
Status
Terminated
Recall initiated
23 Aug 2013
FDA classified
13 Sep 2013
Reported
25 Sep 2013
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

23 Aug 2013Recall initiated by company
13 Sep 2013Classified by FDA+21 days
25 Sep 2013Published in enforcement report+12 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: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

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

NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Is NA Ascorbate 500 mg/mL, PF, Medaus Pharmacy 1-800-526-9183 recalled?

Yes. Medaus recalled NA Ascorbate 500 mg/mL, PF, Medaus Pharmacy 1-800-526-9183 on 23 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1054-2013.

Why was it recalled?

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Which lots are affected?

LOT # 130702-1, Exp 12/29/2013

Where was it sold?

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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