Drug Enforcement D-0574-2023

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

Status

Terminated

Classification

Class II

Report Date

May 24, 2023

Termination Date

December 12, 2023

Product Information

Product description
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.
Product quantity
1,352,475 vials
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Hikma Pharmaceuticals USA Inc.
Address
2 Esterbrook Ln, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0574-2023
Event ID
92320
Recall initiation date
May 11, 2023
Center classification date
May 15, 2023
Code info
Lots: 070086, 070128, Exp. 07/2023
More code info
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