FDAClass IIApril 12, 2023

Rosuvastatin 40mg tablets recall: CGMP Deviations

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Why was Rosuvastatin 40mg tablets recalled?

cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025. Lot #: b): B2080829-012823, B1938007-110222, B2038746-123022, Exp. Date 07/31/2025.

Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Recalling firm
RemedyRepack Inc.
Quantity
a) 76 bottles, b)151 bottles
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Recall date
April 12, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls