FDA recall D-0521-2023

Preferred Pharmaceuticals, Inc. · Class II · drug

Product

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9

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-0521-2023