FDA Recalls Potentially Mislabeled Sirolimus Tablets Distributed by Aidapak Services
Aidapak Services is recalling 1 mg Sirolimus tablets that may be mislabeled as Propranolol or Hydrocortisone. The repacked drugs were distributed in four western states.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the hazard involves potential serious adverse health consequences from medication errors.
Plain-English summary
Aidapak Services, LLC is recalling 1 mg Sirolimus tablets (NDC 00008104105) that may be potentially mislabeled as other medications. The specific products involved include lots with pedigree AD60272_43 (expiration 5/22/2014) and W003329 (expiration 6/18/2014). The recall is due to a label mixup where these Sirolimus tablets may be incorrectly identified as Propranolol HCL 10 mg or Hydrocortisone 5 mg.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Because the mislabeled products could lead to patients receiving the wrong medication, the FDA has classified this as a Class II recall. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received Sirolimus tablets that appear to be labeled as Propranolol HCL or Hydrocortisone. Do not take the medication if there is any uncertainty regarding the label or product identity.
The recalled product
- Product
- SIROLIMUS, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008104105.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- SIROLIMUS
- Tablet
- 1 mg has the following product codes: Pedigree: AD60272_43
- EXP: 5/22/2014
- Pedigree: W003329
- EXP: 6/18/2014.
Distribution
Part of a larger recall action
This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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