Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free recall
FDA recall D-0508-2024 · initiated Apr 29, 2024
Hikma Injectables USA Inc recalled Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free in Apr 2024 — an FDA Class I recall (D-0508-2024) because Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Hikma Injectables USA Inc
- Classification
- Class I
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- CO, GA, PA, SD, WA
- Initiated
- Apr 29, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free recalled?
- Hikma Injectables USA Inc recalled Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free in Apr 2024 — an FDA Class I recall (D-0508-2024) because Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free recalled?
- Per the FDA enforcement record, the reason for recall D-0508-2024 was: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
- Is a recalled Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free are affected?
- Distributed: CO, GA, PA, SD, WA. The recall covers these lots — Lot #: 240310003D, Exp 6/4/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0508-2024.