LORazepam Injection — Class II drug recall D-0576-2023
Terminated recall by RemedyRepack Inc., reported 2023-05-24. CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the ide
| Recall number | D-0576-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-05-24 |
| Terminated | 2023-06-21 |
| Quantity | 9,038 vials |
| Reason classes | potency, cgmp |
| NDC | 17478-0040-01, 70518-2268-00 |
| Lot numbers | B1140139-040821, B1163740-042921, B1163745-042921, B1163747-042921, B1203592-052721, B1203608-052721, B1234313-061721, B1234339-061721, B1274052-071521, B1274069-071521, B1274079-071521, B1353451-091721, B1353463-091721, B1353480-091721, B1383214-100721, B1383216-100721, B1396346-101421, B1455889-112621, B1455901-112621, B1455918-112621, B1498175-122921, B1498194-122921, B1518050-011222, B1539158-012822, B1563407-021422, B1563498-021422, B1617673-032422, B1617737-032422, B1617744-032422, B1660244-042522, B1660288-042522, B1711316-060222, B1711328-060222, B1866210-092222, B1878510-092922, B1904609-101322, B1970782-112122, B2005333-120922, B2005343-120922, B2027905-122222 and 14 more |
| Expiration dates | 2023-05-31, 2023-09-30, 2024-01-31, 2024-03-31, 2024-04-30, 2024-05-31, 2024-06-30, 2024-07-31, 2024-09-30, 2024-11-30, 2024-12-31, 2025-01-31, 2025-03-31, 2025-04-30 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0576-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.