D-1290-2015 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
98 mL

Product Description

S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

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 #: 04302015@66, BUD 06/29/2015