FDA recall D-1295-2015

Product

SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57

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-1295-2015