January 2018 FDA Recall Drug by The Compounding Pharmacy Of America
D-0600-2018 - Non-Sterility

This Class I drug recall was voluntarily initiated by The Compounding Pharmacy Of America on January 12, 2018 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in TN, SC and the recall is currently terminated.

Recall Number: D-0600-2018

Reason for Recall
Non-Sterility
Initiated
01-12-2018
Reported
02-21-2018
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79168
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.
The Compounding Pharmacy of America
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.
TN, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892

Batch or Lot Expiration Information

Lot# Lot: 01052018@46 Use By: 2/9/2018