D-1304-2015 Class II Terminated

Recalled by The Apothecary Shoppe LLC — Tulsa, OK

Recall Details

Product Type
Drugs
Report Date
August 12, 2015
Initiation Date
June 26, 2015
Termination Date
February 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2.5 mL

Product Description

SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70

Reason for Recall

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Distribution Pattern

Oklahoma

Code Information

Lot #: 03192015@27, BUD 07/13/2015