FDA recall D-1290-2016

Product

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Key facts

Status

Terminated

Initiation date

2016-04-20

Report date

2016-07-20

Termination date

2018-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1290-2016