Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack I
Summary
The FDA issued a Class II for Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Bal by RemedyRepack Inc.. Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet..
Details
Source
Drug Recall
External ID
D-1538-2022
Action Date
2022-09-21
Status
Terminated
Category
drug
Product Description
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Lot/Code Info: Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Quantity Affected: 1,699 blister cards/30 tablets each
Reason for Recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Distribution
Distributed to two direct accounts in PA and AK.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-15
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 76 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-1538-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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