FDA recall D-1077-2019

Product

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

Reason for recall

Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2019-04-10

Termination date

2021-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Deptford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2019