CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Ativan Injection (lorazepam injection, USP), 2mg/mL vial recalled
Hikma Pharmaceuticals USA is recalling Ativan Injection (lorazepam injection, USP), 2mg/mL vial, 25 vials per, distributed nationwide in the US. The recall was initiated on 11 Jul 2022 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-1308-2022
- FDA event ID
- 90583
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2022
- FDA classified
- 5 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 11 Jul 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +25 days |
| 17 Aug 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Which lots are affected?
Lot # 060064Z, Exp. 06/2023
Where was it sold?
Nationwide in the USA
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 1 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90583| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lorazepam Injection, USP, 2mg/mL vial, 25 vial recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS II | Lorazepam Injection, USP, 4mg/mL vial, 25 vial recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS II | Lorazepam Injection, USP, 2mg/mL vial, 25 vials recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
More recalls from Hikma Pharmaceuticals USA
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |