September 2017 FDA Recall Drug by Rxq Compounding Llc
D-0012-2018 - Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

This Class II drug recall was voluntarily initiated by Rxq Compounding Llc on September 25, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.. The product was distributed in TX, LA, PA, MA, FL, and OH and the recall is currently terminated.

Recall Number: D-0012-2018

Reason for Recall
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Initiated
09-25-2017
Reported
10-25-2017
Quantity
945 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78175
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RXQ Compounding LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX, LA, PA, MA, FL, and OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

Batch or Lot Expiration Information

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