September 2018 FDA Recall Drug by Tailor Made Compounding
D-0223-2019 - Labeling

This Class II drug recall was voluntarily initiated by Tailor Made Compounding on September 28, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0223-2019

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Initiated
09-28-2018
Reported
11-14-2018
Quantity
10,280 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81337
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.
Tailor Made Compounding
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2019
Product Description About Product Description
Full technical description of the product.
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

Batch or Lot Expiration Information

Lot# Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19