FDA recall D-1300-2015

The Apothecary Shoppe LLC · Class II · drug

Product

SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43

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

Oklahoma

Key facts

Status
Terminated
Initiation date
2015-06-26
Report date
2015-08-12
Termination date
2017-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1300-2015