Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

RemedyRepack Inc.

NDC code

70518-3519-00

Origin

PA, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0500-2023

Other Rosuvastatin recalls

See all

Class II · Moderate risk Ongoing Dec 31, 2025

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478…

Reason Out of specification for dissolution.

AvKARE D-0292-2026

Class II · Moderate risk Ongoing Mar 13, 2025

Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-264-30 D-0339-2025

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1311-01 D-0502-2023