Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination
RemedyRepack Inc. is recalling Lisinopril 10 mg prescription tablets due to a metal fragment embedded in one tablet. Affected lots were distributed to pharmacies in Pennsylvania and Alaska.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a foreign object (metal fragment) in a prescription medication, which presents a risk of harm to patients who ingest it. No illnesses or injuries have been reported. Per the FDA severity rubric, a risk-of-harm product without reported injury is classified as High (3).
Plain-English summary
RemedyRepack Inc. is recalling specific lots of Lisinopril 10 mg prescription tablets due to the discovery of a metal fragment embedded in one tablet.
The recall affects 1,699 blister cards (30 tablets per card) with lot numbers J0636336-073022 and J0637605-080422, expiring 08/31/2023. The medication was distributed to two direct accounts in Pennsylvania and Alaska.
If you have received medication with these lot numbers, contact your healthcare provider or pharmacist immediately. Do not use tablets from the affected lots without first consulting your healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # J0636336-073022
- J0637605-080422
- Exp. date 08/31/2023
Distribution
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