PlainRecalls
FDA Drug Moderate Class II Ongoing

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703

Reported: April 12, 2023 Initiated: March 23, 2023 #D-0512-2023

Product Description

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), 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) 375 Bottles b) 323 Bottles
Distribution
USA Nationwide
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: a) 375 Bottles b) 323 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-0512-2023.