RemedyRepack Inc.: Drug Recall
Recall #D-0576-2023 · 05/01/2023
Class II: Risk
Recall Details
- Recall Number
- D-0576-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- RemedyRepack Inc.
- Status
- Terminated
- Date Initiated
- 05/01/2023
- Location
- Indiana, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,038 vials
Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Product Description
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
Distribution Pattern
Product was distrituded to three direct account in PA.
Other Recalls by RemedyRepack Inc.
- Class II: Risk 04/22/2025
- Class II: Risk 03/24/2025
- Class II: Risk 01/24/2025
- Class II: Risk 12/02/2024
- Class II: Risk 06/26/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.