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

FDA recall notice · announced October 25, 2017 · Rxq Compounding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: TX, LA, PA, MA, FL, and OH
Lot/code information: Lot: 04252017@1, exp 5/9/2018
Quantity: 945 vials
Status: Terminated
Products in this recall event:
- methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10 (D-0012-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.