September 2018 FDA Recall Drug by Rxq Compounding Llc
D-0130-2019 - Subpotent drug

This Class II drug recall was voluntarily initiated by Rxq Compounding Llc on September 25, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0130-2019

Reason for Recall
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Initiated
09-25-2018
Reported
10-31-2018
Quantity
395 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81316
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2022
Product Description About Product Description
Full technical description of the product.
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450

Batch or Lot Expiration Information

Lot# 04042018:58, Exp 10/17/18