PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: April 12, 2023 Initiated: March 23, 2023 #D-0519-2023

Product Description

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.

Details

Units Affected
a) 59 Bottles, b) 77 Bottles
Distribution
USA Nationwide
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: a) 59 Bottles, b) 77 Bottles.
Why was this product recalled?
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0519-2023.