FDAClass IIAugust 17, 2022

Lorazepam Injection recall: Impurity Out of Spec

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC#…

Why was Lorazepam Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 070088, exp. date 07/2023

Product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC#…
Recalling firm
Hikma Pharmaceuticals USA Inc.
Quantity
713,550 vials
Distribution
Nationwide in the USA
Recall date
August 17, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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