phenylephrine in 0.9% Sodium Chloride Inj recall: Sterility Concern
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…
Why was phenylephrine in 0.9% Sodium Chloride Inj recalled?
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
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 number: 243120003D, Use by Date: 03/11/2025
- 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…
- Recalling firm
- Hikma Injectables USA Inc
- Distribution
- Nationwide in the USA
- Recall date
- January 8, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)