August 2016 FDA Recall Drug by Town And Country Compounding And Consultation Services
D-0228-2017 - Non-Sterility; microbial contamination identified as Bacillus circulans

This Class I drug recall was voluntarily initiated by Town And Country Compounding And Consultation Services on August 1, 2016 for the product Drug. The FDA reported the reason for recall as non-sterility; microbial contamination identified as bacillus circulans. The product was distributed in MA, NY, NJ & FL; Canada and the recall is currently terminated.

Recall Number: D-0228-2017

Reason for Recall
Non-Sterility; microbial contamination identified as Bacillus circulans
Initiated
08-01-2016
Reported
12-28-2016
Quantity
12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74938
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MA, NY, NJ & FL; Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-08-2019
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502

Batch or Lot Expiration Information

Lot# 07172016@1, exp 1/13/2017