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Class II · ModerateRecall completed

Lorazepam

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 070088, exp. date 07/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Berkeley Heights, NJ 07922. Carton
Brand nameLORAZEPAM
Generic nameLORAZEPAM
Active ingredient(s)LORAZEPAM
Distributed by / forHikma Pharmaceuticals USA Inc.
NDC0641-6048-25
Show the full FDA record
Full product labelLorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide in the USA
Quantity713,550 vials
Recall initiated2022-07-11
Report date2022-08-17
Recall completed2023-09-14
Recall numberD-1309-2022
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.