FDA recall D-1229-2019

CMC Enterprise Pharmacy · Class II · drug

Product

Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for recall

Lack of sterility assurance.

Distribution

NC

Key facts

Status
Terminated
Initiation date
2019-04-12
Report date
2019-05-01
Termination date
2019-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlotte, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1229-2019