WhichRecall
Class IIReported 2025-01-08

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Recalled by Hikma Injectables USA Inc

Reason for Recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

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Recall Number
D-0174-2025
Classification
Class II
Status
Terminated
Category
drug
Initiated
2024-12-19
Reported
2025-01-08
Distribution
Nationwide in the USA
Code Info
Lot number: 243120003D, Use by Date: 03/11/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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