Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
S2 Racepinephrine Inhalation Solution (Racepinephrine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Short Fill
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9
Affected NDC
0487-5901-99
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| S2 racepinephrine hydrochloride NDC 00487-5901 |
11.25 mg/.5mL | Solution Respiratory (inhalation) |
Nephron Pharmaceuticals Corporation | OTC |
- Recalling firm
- Nephron Sc Inc
- NDC code
- 0487-5901-99
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0176-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epinephrine recalls
See all
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by Nephron Sc Inc
All 2023 recalls
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
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