Lorazepam Injection recall: Impurity Out of Spec
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Why was Lorazepam Injection recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
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?
Lots: 070086, 070128, Exp. 07/2023
- Product
- Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Quantity
- 1,352,475 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 24, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)