Food, drugs, devices › RemedyRepack Inc.
Drug recall: Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack I
RemedyRepack Inc. (Indiana, PA) initiated this drug recall on 15 Sep 2022; FDA lists 1 product record under event 90873, classified Class II.
FDA defines Class II as 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. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 16 Nov 2022. Initiation: voluntary: firm initiated. RemedyRepack Inc. has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
RemedyRepack Inc., Indiana, PA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1538-2022 | 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 | 1,699 blister cards/30 tablets each | Class II | Terminated | 21 Sep 2022 |
Context
Other enforcement events for RemedyRepack Inc.
All 36 events for RemedyRepack Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to two direct accounts in PA and AK."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Nov 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.