FDAHealthDecember 19, 2024
Hikma Injectables USA Inc — 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
⚠️ Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2024
Nationwide in the USA
What's affected?
- Product
- 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
- Lot code
- 243120003D
Additional details
Lot number: 243120003D, Use by Date: 03/11/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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