Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles
Summary
The FDA issued a Class II for Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 an by RemedyRepack Inc.. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0501-2023
Action Date
2023-04-12
Status
Terminated
Category
drug
Product Description
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Lot/Code Info: Lot#: a) NDC 70518-0375-03: J0674788-011123, Exp. Date 01/31/2024; J0664118-112922 J0664118-112922, Exp. Date 12/31/2023; J0653727-101722, Exp. Date 10/31/2023. NDC 70518-0375-01: B2057931-011223, Exp. Date 07/31/2025 b) Lot #: B2075815-012523, Exp. Date 09/30/2025; B2011634-121322, Exp. Date 07/31/2025 B1970205-112022, Exp. Date 06/30/2024; B1862598-092022, Exp. Date 03/31/2024; B2077226-012523, B2070444-012023, Exp. Date 07/31/2025.
Quantity Affected: a) 399 bottles, b)445 bottles
Reason for Recall
cGMP Deviations
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-20
Company
Indiana, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 70 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RemedyRepack Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RemedyRepack Inc. have FDA actions?
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0501-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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