Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Pseudoephedrine HCL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.
What was recalled
PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-475-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ephedrine recalls
See all
Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Ongoing
Ephedrine Sulfate Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Short Fill
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
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