Recalls / Class II

Class IID-0012-2018

Product

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

RXQ Compounding LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

340 W State St Unit 9, Athens, Ohio 45701-1564

Distribution

Quantity

945 vials

Distribution pattern

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

Timeline

Recall initiated

2017-09-25

FDA classified

2017-10-18

Posted by FDA

2017-10-25

Terminated

2017-12-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.