D-1538-2022 Class II Terminated
FDA drug recall D-1538-2022 was initiated by RemedyRepack Inc. on Sep 15, 2022 and is designated Class II. Reason for recall: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. The recall status is terminated (terminated Nov 16, 2022). Affected quantity: 1,699 blister cards/30 tablets each.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 21, 2022
- Initiation Date
- Sep 15, 2022
- Termination Date
- Nov 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,699 blister cards/30 tablets each
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
Reason for Recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Distribution Pattern
Distributed to two direct accounts in PA and AK.
Code Information
Lot # J0636336-073022, J0637605-080422, Exp. date 08/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1538-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026