MethylPREDNIsolone ACETATE recalled over sterility concerns
- Recall date
- September 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- RXQ Compounding LLC recalls methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-…
- Recall number
- D-0012-2018
- FDA classification
- Class II
- Brand / firm
- RXQ Compounding LLC
- Sold / distributed
- TX, LA, PA, MA, FL, and OH
Why it was recalled
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
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