October 2013 FDA Recall Drug by Specialty Medicine Compounding Pharmacy, P.c.
D-1156-2014 - Non-Sterility

This Class I drug recall was voluntarily initiated by Specialty Medicine Compounding Pharmacy, P.c. on October 19, 2013 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in Hospitals, clinics, physicians, and patients in the Michigan area only. and the recall is currently terminated.

Recall Number: D-1156-2014

Reason for Recall
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Initiated
10-19-2013
Reported
03-19-2014
Quantity
1000 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67214
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.
Specialty Medicine Compounding Pharmacy, P.C.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 07222013@19, 07222013@22, 07222013@23, 07222013@24, Exp 10/20/13; 07232013@1, 07232013@2, 07232013@3, 07232013@5, Exp 10/21/13; 07252013@1, 07252013@3, 07252013@4, 07252013@5, Exp 10/23/13; 07302013@24, 07302013@28, 07302013@30, 07302013@31, 07302013@32, Exp 10/28/13; 08052013@4, 08052013@6, 08052013@7, 08052013@8, 08052013@9, 08052013@10, Exp 11/03/13; 08092013@1, 08092013@8, 08092013@3, 08092013@4, 08092013@5, 08092013@6, Exp 11/07/13; 08122013@1, 08122013@3, 08122013@4, 08122013@5, 08122013@6, 08122013@7, Exp 11/10/13; 08162013@1, 08162013@3, 08162013@4, Exp 11/14/13; 08192013@2, 08192013@4, Exp 11/17/13