Class III · Low risk Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle
Reason Failed Impurities/Degradation Specifications
Sirolimus
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, EXP: 6/18/2014.
What was recalled
SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-779-2014
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 Sirolimus recalls
See all
Class III · Low risk Terminated
Fyarro
Reason Failed Stability Specifications
Class III · Low risk Terminated
Sirolimus Oral Solution
Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk Terminated
Sirolimus Tablets 1 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Sirolimus Tablets
Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.
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