CLASS II Drug recall · Reported 25 Oct 2017 · FDA Enforcement Report
methylPREDNIsolone Acetate, 40 MG/ML Injection Suspension recalled
RXQ Compounding is recalling methylPREDNIsolone Acetate, 40 MG/ML Injection Suspension Vial, Rxq Compounding, Athens, distributed in Florida, Louisiana, Massachusetts, Ohio, Pennsylvania, Texas. The recall was initiated on 25 Sep 2017 and the FDA has classified it as Class II.
Check your package
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-0012-2018
- FDA event ID
- 78175
- Recalling firm
- RXQ Compounding, Athens, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2017
- FDA classified
- 18 Oct 2017
- Reported
- 25 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Sep 2017 | Recall initiated by company | |
| 18 Oct 2017 | Classified by FDA | +23 days |
| 25 Oct 2017 | Published in enforcement report | +7 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; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
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
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Where it was distributed
TX, LA, PA, MA, FL, and OH
Questions about this recall
Is methylPREDNIsolone Acetate, 40 MG/ML Injection Suspension Vial, Rxq Compounding, Athens recalled?
Yes. RXQ Compounding recalled methylPREDNIsolone Acetate, 40 MG/ML Injection Suspension Vial, Rxq Compounding, Athens on 25 Sep 2017. The recall is Class II and its status is Terminated. Recall number D-0012-2018.
Why was it recalled?
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Which lots are affected?
Lot: 04252017@1, exp 5/9/2018
Where was it sold?
TX, LA, PA, MA, FL, and OH
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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|---|---|---|---|---|---|
| Drug | CLASS II | Edetate Calcium Disodium 150MG/ML Injectable per vial recalled | RXQ Compounding | Sterility | Nationwide |
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