CLASS II Drug recall · Reported 28 Feb 2018 · FDA Enforcement Report
Dexamethasone Sodium Phosphate in all strengths, all doses recalled
Pharmedium Services is recalling Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging, distributed nationwide in the US. The recall was initiated on 27 Dec 2017 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes All lots remaining within expiry.
Quantity recalled Unknown
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-0444-2018
FDA event ID 78828
Classification Class II
Status Terminated
Recall initiated 27 Dec 2017
FDA classified 20 Feb 2018
Reported 28 Feb 2018
Type Voluntary: Firm initiated
Customers notified by Press Release
Timeline
27 Dec 2017 Recall initiated by company 20 Feb 2018 Classified by FDA +55 days 28 Feb 2018 Published 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 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
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Where it was distributed
U.S.A. Nationwide
Nationwide
Questions about this recall
Why was it recalled? Lack of sterility assurance.
Which lots are affected? All lots remaining within expiry.
Where was it sold? U.S.A. 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 41 other products · FDA event 78828 This product is part of a recall event; the main page for the event is Glycopyrrolate in all strengths, all doses, and all packaging recalled .
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