October 2016 FDA Recall Drug by Town And Country Compounding And Consultation Services, Llc
D-0436-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Town And Country Compounding And Consultation Services, Llc on October 18, 2016 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-0436-2017

Reason for Recall
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Initiated
10-18-2016
Reported
01-25-2017
Quantity
101 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75700
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Town and Country Compounding and Consultation Services, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2021
Product Description About Product Description
Full technical description of the product.
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

Batch or Lot Expiration Information

Lot# : 05272016@17