April 2016 FDA Recall Drug by Complete Pharmacy And Medical Solutions Llc
D-0918-2017 - Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

This Class I drug recall was voluntarily initiated by Complete Pharmacy And Medical Solutions Llc on April 2, 2016 for the product Drug. The FDA reported the reason for recall as non-sterility - presence of bacteria confirmed by outside laboratory after day 14.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0918-2017

Reason for Recall
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Initiated
04-02-2016
Reported
06-21-2017
Quantity
49 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76681
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Complete Pharmacy and Medical Solutions 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Batch or Lot Expiration Information

Lot# 22016, Exp 1/30/2017