FDA recall D-0519-2023

Preferred Pharmaceuticals, Inc. · Class II · drug

Product

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

Reason for recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2023-03-23
Report date: 2023-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2023