FDA recall D-0012-2018

RXQ Compounding LLC · Class II · drug

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.

Distribution

TX, LA, PA, MA, FL, and OH

Key facts

Status
Terminated
Initiation date
2017-09-25
Report date
2017-10-25
Termination date
2017-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2018