September 2015 FDA Recall Drug by Diabetes Corporation Of America Dba Dca Pharmacy
D-0006-2016 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Diabetes Corporation Of America Dba Dca Pharmacy on September 23, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in KY, OH, TN and the recall is currently terminated.

Recall Number: D-0006-2016

Reason for Recall
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Initiated
09-23-2015
Reported
10-14-2015
Quantity
129 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72271
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.
Diabetes Corporation of America dba DCA Pharmacy
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
KY, OH, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-12-2016
Product Description About Product Description
Full technical description of the product.
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527

Batch or Lot Expiration Information

Lot# : 101614, Exp 4/30/2015