Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
ePHEDrine in 0.9% sodium chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Affected NDC
71286-6004-01
Compare with the code on your package — it is the most precise check available.
Drug: Ephedrine
- Recalling firm
- Central Admixture Pharmacy Services Inc
- NDC code
- 71286-6004-1
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1073-2023 · 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 Ephedrine recalls
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Class II · Moderate risk
Ephedrine Sulfate Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Class II · Moderate risk
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Other recalls by Central Admixture Pharmacy Services Inc
All 2023 recalls
Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
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