FDA recall D-1276-2016

Product

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41

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-1276-2016