Recall: D-0404-2023

Class II - Potentially Harmful

Class IIClassification

2023-02-07Initiated

TerminatedStatus

Accord Healthcare, Inc.Firm

Product

Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.

Reason

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.