Recall archive / FDA drug enforcement

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: Reme... — FDA record D-0576-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: 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.
Classification: Class II
Recalling firm: RemedyRepack Inc.
Quantity: 9,038 vials
Agency-reported status: Terminated
Source record identifier: D-0576-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.

Label field

Details supplied by the agency

Lot, code or applicability

Lot # B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Product was distrituded to three direct account in PA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Pennsylvania

Dates in the source

Report date: May 24, 2023
Recall initiation date: May 1, 2023
Center classification date: Jun 2, 2023
Termination date: Jun 21, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.