Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
ePHEDrine 50mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
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 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
Affected NDC
42852-0805-61
Compare with the code on your package — it is the most precise check available.
Drug: Ephedrine
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- NDC code
- 42852-805-61
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0930-2018 · 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
See all
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
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
Other recalls by Avella of Deer Valley, Inc. Store 38
All 2018 recalls
Class II · Moderate risk
Povidone Iodine
Lack of sterility assurance.
Class II · Moderate risk
Bevacizumab 2.5 mg/0.1 mL
Lack of assurance of sterility
Class II · Moderate risk
MAGnesium 2 gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 2gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
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