FDA recall D-0208-2017

Product

C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067

Reason for recall

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

Distribution

NJ and NY

Key facts

Status

Terminated

Initiation date

2016-07-28

Report date

2016-12-28

Termination date

2023-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colonia, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0208-2017