FDA recall D-1677-2015

Product

Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-02

Report date

2015-09-23

Termination date

2016-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Knoxville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1677-2015