US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

Rosuvastatin Calcium

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

Why it was recalled

Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC 67877029401, Pedigree: W002577, EXP: 6/3/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD21846_49, EXP: 5/1/2014.

What was recalled

ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-887-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Rosuvastatin recalls

See all
Class II · Moderate risk Ongoing

Rosuvastatin Tablets

Reason Out of specification for dissolution.

AvKARE D-0292-2026
Class II · Moderate risk Ongoing

Rosuvastatin Tablets 40mg

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-264-30 D-0339-2025
Class II · Moderate risk Ongoing

Rosuvastatin Tablets

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

Rosuvastatin Tablets

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

Rosuvastatin 40mg tablets

Reason cGMP Deviations

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