FDA Drug Class II — Moderate

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

Hazard

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Products

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Brand
RXQ Compounding LLC
UPC
Lot: 04252017@1, exp 5/9/2018

Units Affected

945 vials