FDA recall D-0525-2023

Product

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., 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-0525-2023