FDA recall D-0606-2016

Product

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reason for recall

Stability data does not support expiry.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-19

Report date

2016-02-03

Termination date

2017-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0606-2016