Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up
Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which per the rubric criteria is classified as Critical. A label mix-up resulting in administration of the wrong drug poses a serious probability of adverse health consequences.
Plain-English summary
Hikma Injectables USA Inc is recalling Phenylephrine in 0.9% Sodium Chloride Injection (preservative free, 100 mcg/mL) in 5 mL syringes due to a labeling error. The product label states the syringes contain Phenylephrine, but they actually contain Ephedrine.
A label mix-up means healthcare providers administering these syringes based on the label will unknowingly give patients Ephedrine instead of Phenylephrine. The recall affects Lot #240310003D (expiration 6/4/2024) distributed to Colorado, Georgia, Pennsylvania, South Dakota, and Washington. Healthcare providers and patients in these states should not use affected units.
Healthcare facilities and pharmacies should immediately stop using any syringes from the recalled lot and remove them from circulation. Patients who received this product should contact their healthcare provider immediately to discuss what medication they actually received. The FDA has classified this as a Class I recall due to the serious risk of medication error.
The recalled product
- Product
- Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
- Manufacturer
- Hikma Injectables USA Inc
- Category
- Drug — Injectable / Prescription
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 #: 240310003D
- Exp 6/4/2024
Distribution
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