CLASS II Drug recall · Reported 24 May 2023 · FDA Enforcement Report
LORazepam Injection, 2mg / mL Single Dose vial vial recalled
RemedyRepack is recalling LORazepam Injection, 2mg / mL Single Dose vial vial, distributed in Pennsylvania. The recall was initiated on 1 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0576-2023
- FDA event ID
- 92239
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2023
- FDA classified
- 2 Jun 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Anxiety & Sleep Medication
Timeline
| 1 May 2023 | Recall initiated by company | |
| 24 May 2023 | Published in enforcement report | +23 days |
| 2 Jun 2023 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
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
Where it was distributed
Product was distrituded to three direct account in PA.
Questions about this recall
Is LORazepam Injection, 2mg / mL Single Dose vial vial recalled?
Yes. RemedyRepack recalled LORazepam Injection, 2mg / mL Single Dose vial vial on 1 May 2023. The recall is Class II and its status is Terminated. Recall number D-0576-2023.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Product was distrituded to three direct account in PA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Lorazepam recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 5mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Oral Concentrate, USP, 2mg per mL recalled by Akorn | Akorn | Sterility | Nationwide |