Injectable phenylephrine recalled due to defective tamper-evident seals nationwide
Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving defective sterility assurance on a sterile injectable medication. No illnesses or injuries have been reported. The hazard qualifies as a risk-of-harm product without yet-reported injury, warranting a High severity rating.
Plain-English summary
Hikma Injectables USA Inc. is recalling phenylephrine in 0.9% Sodium Chloride Injection (1 mg per 10 mL) nationwide due to a manufacturing defect. The tamper-evident seals on several syringes in the recalled lot were not properly attached upon receipt of shipment, compromising the assurance of sterility.
The affected product is lot number 243120003D with a use-by date of 03/11/2025. This is a prescription-only medication distributed nationwide in the United States.
Patients or healthcare providers who have received this product should contact their pharmacy or healthcare provider immediately. Do not use syringes from this lot if the tamper-evident seal is visibly damaged, missing, or detached. Return the product to the pharmacy for proper disposal or replacement.
The recalled product
- 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
- Manufacturer
- Hikma Injectables USA Inc
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- seal-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number: 243120003D
- Use by Date: 03/11/2025
Distribution
Distributed nationwide across the United States.
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