Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0012-2018

September 25, 2017

Class II

Product summary

Firm
RXQ Compounding LLC
Event
Event 78175
Status
Terminated
Classification
Class II
Quantity
945 vials
Official record key
drug-enforcement:D-0012-2018

Official wording

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

Code information: Lot: 04252017@1, exp 5/9/2018

Distribution pattern: TX, LA, PA, MA, FL, and OH

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility